Oral care products make up a large part of the cosmetic industry and help keep our oral cavities in good condition. In this article, you will learn about tooth anatomy, the formulation, ingredients, regulation and claims of oral care products including toothpastes and mouthwashes.
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tooth Anatomy
Sections of the tooth
Crown – visible portion of tooth above the neck and extending out of the gum tissue.
Neck – also known as the cementoenamel junction (CEJ) or cervical line. Allows for the attachment of gums (gingivae). This is where the crown’s enamel layer meets the cementum layer of the root. This line is often curved and irregular around the tooth
Root – the tooth’s largest portion which extends from the neck to the apex. It’s secured to a socket (alveolar process) in the mandible or maxilla (jawbones).
Tissue Types
External
Enamel is the toughest part of the tooth, it has no vessels, nerves or living cells. It’s made up of dense minerals (96%) such as hydroxyapatite. Key-shaped prism rods run in waves perpendicular to the tooth’s surface. It can be dissolved by acids produced by dental plaque which cause cavities (caries). The enamel is temporarily weakened after acid-consumption (e.g. citric acid) so it’s recommended to wait a minimum of 30 minutes before brushing the teeth which could erode the enamel.
Cementum is the hardened bone-like tissue that covers the tooth’s root. It’s formed by cells called cementoblasts which have a light-yellow appearance. It has a low-mineral composition (45%), making it softer than other parts of the tooth. The periodontal ligament surrounds and attached to the cementum, anchoring it to the alveolar process (bone) in the maxilla or mandible (jawbones).
Periodontium is the tissue that surrounds and supports the teeth which includes the gingivae (gums), cementum, periodontal ligament and alveolar bone.
Internal
Dentin is a hardened tissue that sits beneath the enamel and cementum layer. They are formed and maintained by cells called odontoblasts. It makes up most of the tooth’s mass and is made up of 70% minerals.
Dentinal tubules run through dentin in parallel, originating at the pulp cavity and terminating before the enamel or cementum. Toothache occurs when these tubules are affected by heat or cold as they are connected to the pulp.
The dentinoenamel junction (DEJ) is where the dentin meets the enamel at the crown of the tooth. The dentinocemental junction (DCJ) is where the dentin meets the cementum.
Dental pulp is the soft tissue located in the pulp cavity of the tooth. Pulp cavity consists of a narrow root canal and larger pump chambers. The root canal originates at a small hole in the apex of the root called the apical foramen. It continues along the root and expands into a larger pulp chamber within the crown. The dental pulp tissue consists of odontoblasts, vessels and nerves. These provide the tooth’s sensation, nutrition, immune defence as well as secretions that maintain dentin.
Types of teeth
Incisor
Canine
Premolar
Molar
Oral Care Product Types
Toothpaste
A toothpaste is a semi-solid material for removing naturally occurring deposits from teeth and is supposed to be used simultaneously with a toothbrush to brush the teeth (and occasionally tongue).
The earliest known toothpaste was used around 5000 BCE in ancient Egypt. Egyptians created a powder made from crushed eggshells, ox hooves, ashes, and pumice to clean teeth. Other early civilizations like the Greeks and Romans also used abrasive powders made from similar materials. Watch a video about the earliest toothpastes: click here to view.
Around 500 BCE, people in China and India developed toothpaste formulas that included herbal ingredients such as ginseng, salt, and mints to clean the teeth and freshen breath.
The Romans introduced the use of more abrasive substances like crushed bones and oyster shells, while the Greeks added crushed bones and charcoal to help scrub the teeth clean.
Tooth cleaning powders became popular in the 1800s, especially in Europe and America. These powders often contained chalk, salt, and baking soda. They were harsh on teeth but somewhat effective at removing plaque and debris.
The first commercial toothpaste in a jar was introduced in the 1850s by Dr. Washington Sheffield in the U.S. His product, called “Crème Dentifrice,” was an improvement over powders as it was paste-based and more convenient to use.
The switch from jars to collapsible tubes came in the late 19th century. Colgate introduced its first toothpaste in a tube in 1896, making the product more hygienic and easier to dispense.
One of the biggest innovations came in 1914 when fluoride was first added to toothpaste. This was a major breakthrough in preventing tooth decay, as fluoride strengthens enamel and prevents cavities. Fluoride toothpaste became widely accepted after World War II, especially after studies proved its effectiveness in preventing dental caries.
The 1960s saw the introduction of toothpaste for specific dental concerns, such as tartar control and whitening. Manufacturers began adding ingredients like hydrogen peroxide for whitening and zinc citrate for plaque reduction.
In the 1980s, gel toothpastes became popular as a more visually appealing and smoother alternative to pastes. They often contained additional flavoring and coloring agents to attract consumers.
In recent years, there has been a growing demand for natural and eco-friendly toothpaste products. These often avoid synthetic chemicals and are made with organic ingredients like coconut oil, aloe vera, and charcoal.
Mouthwash
A mouthwash is defined as a non-sterile aqueous solution used mostly for its deodorant, refreshing or antiseptic effect. Mouthwashes or rinses are designed to reduce oral bacteria, remove food particles and temporary reduction in bad breath.
3000 BCE, ancient Egyptians used mixtures of water and various herbs to rinse their mouths, primarily for fresh breath rather than hygiene. In ancient Rome, mouth rinses were more rudimentary, with some evidence suggesting people used urine due to its ammonia content, believed to have cleaning properties. In traditional Chinese and Indian Ayurvedic medicine, rinses were made from herbal infusions to freshen breath and promote health. The herbs often had antibacterial properties.
In the late 1700s, mouthwash began to be discussed in the scientific community, particularly as awareness of bacteria and hygiene grew. However, these early antiseptic mouthwashes were relatively primitive, often based on mixtures of vinegar, salt, and water. Mouthwash became more standardized during this period, and some early formulations were developed based on the work of doctors experimenting with antiseptics for surgery. Joseph Lister, a British surgeon, pioneered the use of antiseptics in the 1860s, which would inspire later developments in oral care.
In 1879, Dr. Joseph Lawrence developed Listerine, originally formulated as a surgical antiseptic. It was later marketed as a floor cleaner, a treatment for gonorrhea, and eventually as a mouthwash in the early 20th century (around 1914). Listerine, named after Joseph Lister, became the first widely available commercial mouthwash, marking a significant turning point in oral hygiene. It was marketed to help freshen the breathe.
After the successful introduction of fluoride in toothpaste, the 1950s saw the first fluoride-based mouthwashes designed to fight tooth decay and strengthen enamel. These fluoride rinses became an important adjunct to dental care, helping to reduce cavities and improve overall oral health.
By the mid-20th century, mouthwash products began to diversify into two main categories: cosmetic (to freshen breath) and therapeutic (to fight dental plaque, gum disease, and tooth decay). Products designed specifically for gum health, such as those containing chlorhexidine, were introduced to target gingivitis and plaque buildup.
Throughout much of the 20th century, most mouthwashes were alcohol-based, as alcohol was believed to kill bacteria effectively. However, these formulas often caused discomfort for people with sensitive gums or dry mouth, prompting the development of alcohol-free alternatives later on.
In response to concerns about the harshness of alcohol-based mouthwashes, manufacturers began producing alcohol-free options. These are less irritating to sensitive gums and are more suitable for people with conditions like xerostomia (dry mouth).
Dental/Oral Issues
Oral care products’ main role is to prevent the formation of dental/oral care issues through regular use of toothpastes and mouthwashes. Cosmetic products cannot treat any of these issues, their only role is to prevent and manage – not treat.
Oral Plaque( Dental Biofilm)
Plaque forms when oral bacteria adhere to the pellicle, a protein film on the enamel. Initially, aerobic Gram-positive bacteria like Streptococci colonise the plaque, feeding on dietary sugars and starches. This produces lactic acid and sticky polysaccharides that bind the plaque together. This early plaque, found above the gumline, is called ‘supragingival plaque’.
The polysaccharides become a substrate for secondary colonisers, including anaerobic Gram-positive and Gram-negative bacteria such as Lactobacilli, Porphyromonas gingivalis, Actinomycetes, Fusobacterium nucleatum, as well as yeasts, viruses, protozoa, antibodies, and white blood cells. These organisms feed on proteins from the oral cavity and other plaque bacteria, producing acids, amines, ammonia, and volatile sulphur compounds. This more mature plaque forms below the gumline and is known as ‘subgingival plaque’.
Dental Calculus (Tartar)
Calculus is a hard, crystalline deposit ranging from white to dark brown, primarily forming near the gums and around salivary glands at the front lower teeth and back upper teeth. It consists mostly of inorganic calcium phosphate, along with bacteria, lipids, carbohydrates, and proteins. Strongly attached to teeth, calculus resembles dentine and is best removed by a dental professional using specialised tools.
Periodontal Disease (Gum Disease)
Periodontal disease involves inflammation of the gums (gingivitis) or the periodontium (periodontitis, which affects the gums, connective tissue, and underlying bone and ligaments). It affects about half of the population and becomes more common with age. Plaque and calculus buildup can cause periodontal disease through physical irritation and reaction to bacteria and toxins. Other factors include diet, lifestyle (such as smoking), genetics, age, and over-scrubbing the gums with a hard toothbrush.
Dental Caries (Cavities)
Dietary fermentable carbohydrates, like sugars, are metabolised by plaque bacteria to produce acid. Saliva usually washes this away, keeping plaque at a neutral pH and allowing enamel to remineralize. Dental caries occur with extended or frequent intake of these carbohydrates, causing the plaque pH to drop below 5.5. This prolonged acidity leads to enamel demineralization, which can surpass the remineralization process, resulting in enamel and dentine loss.
If the top layer of hydroxyapatite isn’t re-formed properly, underlying enamel demineralizes, forming pits that appear as white spots, or ‘precarious lesions’. These pits fill with bacteria, accelerating demineralization and eventually causing cavities.
Dental Erosion (Tooth Wear)
Tooth wear is a common condition that occurs through erosion, abrasion, or attrition.
Erosive tooth wear, like decay, results from low oral pH and enamel dissolution but occurs at the tooth surface without bacterial action. It can be caused by acidic foods and drinks or internal factors like stomach acid regurgitation.
Abrasive tooth wear can be due to excessive brushing—too long, too vigorously, or with a hard brush. Highly abrasive toothpastes or powders can also cause it. This wear often occurs at the gingival margin, where the enamel is thinner and gums are prone to inflammation.
Attrition results from excessive tooth grinding or clenching, as well as the use of mouth jewellery like tongue or cheek piercings.
Tooth Discoloration (Stain)
Tooth stain is a cosmetic issue primarily affecting the enamel’s surface. Natural tooth color is influenced by the thickness and translucency of the white enamel over the yellow dentine. External staining involves the pellicle, plaque, and calculus, and is more common on rough enamel, irregular teeth, poor oral hygiene, and high consumption of staining substances. Regular brushing and certain oral care products can control external staining, but severe cases may need professional cleaning.
Cracks in the enamel can lead to deeper, harder-to-remove stains. Intrinsic stains, however, are not reversible with toothpaste and may require peroxide or bleaching treatments for management.
External Causes of Tooth Staining
- Foods/drinks containing chromogens including tea, coffee, turmeric, red wine.
- Tobacco smoke.
- Complexing of the pellicle with metal ions such as tin.
- Chemical degradation reactions involving pellicle proteins and carbohydrates, e.g. the Maillard reaction (which is what happens when fruit goes brown).
Intrinsic Causes of Tooth Staining
- Enamel can be ‘stained’ from within by early childhood exposure to higher levels of fluoride (causing white or brown spots on the teeth.
- Some antibiotics, such as tetracycline, can stain developing permanent teeth (or the first set of teeth of an infant if taken by their mother when pregnant), appearing as yellow, brown or grey bands; minocycline use can sometimes lead to staining of permanent teeth in an adult.
- If a tooth is injured and exposed to internal blood, reddish brown iron may be left in the dentine, causing a darker yellow or brown tooth.
Fluorosis
Fluorosis is the excessive deposition of fluoride in teeth, occurring when a child’s developing permanent teeth (ages 0-6) are exposed to high fluoride levels from multiple sources, such as fluoride tablets or drops, non-municipal water, and toothpaste. Toothpaste alone is not typically responsible for causing severe fluorosis. While fluorosis does not damage the teeth, it can cause areas of enamel opacities (white spots) that generally fade over time.
Dentinal Hypersensitivity (Sensitive Teeth)
Sensitivity causes short, sharp pain when teeth are exposed to cold, hot, or other stimuli. Enamel erosion and receding gums can expose dentine, both above and below the gumline. When dentine tubules lose their sealed tops, they form a passage to the odontoblasts, which connect to nerve endings in the pulp. Various stimuli, such as temperature changes, pH shifts, tactile pressure, or osmotic pressure, can move the liquid inside these tubules, triggering pain.
Dentinal hypersensitivity can result from poor dental hygiene, enamel loss, or gum recession due to over-vigorous brushing. However, not all exposed dentine causes sensitivity, as a protective ‘smear layer’ may form, which includes calcium and toothpaste ingredients. This layer can be removed by acidic foods, drinks, or excessive brushing.
To counteract sensitivity, maintain good dental hygiene, use over-the-counter products designed for sensitivity, or seek specialised treatments from a dental professional.
Oral Malodour (Bad Breath)
Bad breath can result from consuming certain foods (e.g., garlic, tobacco smoke) or from oral bacteria breaking down proteins in saliva, producing sulphur-containing chemicals like mercaptans/thiols (responsible for the ‘asparagus smell’ in urine) and hydrogen sulphide (the ‘rotten egg’ smell). Regular oral hygiene to remove stagnant saliva and, if needed, using an antimicrobial mouthwash can help combat oral malodor.
Ingredients in Oral Care Products
Fluoride containing ingredients in oral care products
Fluoride is the most well-known active ingredient in toothpaste, added for many years. According to the FDI World Dental Federation, “regular use of fluoride toothpaste is scientifically recognized as a major means to reduce the prevalence and severity of dental caries and delay its onset.” Fluoride binds to calcium and phosphate in the oral cavity during enamel remineralization to form hydroxyfluorapatite, which demineralizes at a pH of 4.5, compared to 5.5 for hydroxyapatite. This lower demineralization pH makes fluoride an effective anti-cavity agent.
Fluoride comes in various forms, such as sodium monofluorophosphate (SMFP), sodium fluoride (NaF), stannous fluoride (SnF₂), and amine fluoride (AmF). The choice of fluoride depends on formulation considerations that keep it active, avoiding interactions that render it inactive. Other toothpaste goals (e.g., anti-sensitivity, anti-gingivitis), taste, and cost also influence formulation choices. Some ingredients, like xylitol, can work synergistically with fluoride to enhance its effectiveness in reducing caries.
For those with higher caries risk or wearing orthodontic appliances, fluoride mouthwash (typically around 250 ppm in Europe) can supplement toothbrushing, providing continuous fluoride exposure. Prescription toothpastes with higher fluoride concentrations (2800 and 5000 ppm) are also available for at-risk patients under dental supervision.
Abrasive ingredients in oral care products
An abrasive in toothpaste typically contains an inert, insoluble material used to physically remove food debris, stained pellicle, and plaque. Common abrasives include hydrated silica (similar to sand), sodium bicarbonate (baking soda), alumina (aluminium oxide), calcium carbonate (chalk), calcium pyrophosphate, and sodium metaphosphate.
These abrasives can also serve as thickening, anti-caking, bulking, pacifying, absorbent, and dispersant agents.
One of the major properties of an abrasive is its hardness. The degree of abrasivity depends on the hardness of the abrasive, the morphology of the particles, and the concentration of the abrasive in the paste. Since the hardness of enamel on the tooth surface is 6-7 on the Mohs scale, the hardness of an abrasive should be 3 or less. Practically, the particle size should be 20μm or smaller; larger particles can damage the tooth surface and gums. The abrasives in toothpaste are often not as hard as enamel, but as hard or harder than dentin. Abrasives are typically found as crystals, with small and smooth particles preferred to avoid tooth wear. Needle and rod-shaped particles should be avoided.
Examples of abrasive ingredients
The most frequently used abrasives are dental-grade silicas (SiO₂), also found in sand, produced through gel, pyrogenic, or precipitation processes. Silicas can make up 5 – 15% of toothpaste, with particle size adjustable to change abrasivity. Hydrated silica is used for clear gel toothpastes. Calcium carbonate (CaCO₃), which can constitute up to 40% of toothpaste, is another common abrasive, though it can react with water-soluble fluoride (e.g., NaF) to form insoluble calcium fluoride, making fluoride unavailable to enamel. It is less reactive with fluoride when formulated as SMFP. Alumina (Al₂O₃) is low-cost, has good flavour compatibility, and works well with SMFP, but it can be highly abrasive and must be controlled to prevent forming insoluble salts with water-soluble fluoride.
Anti-sensitivity ingredients in oral care products
To combat dentinal hypersensitivity, there are two primary strategies: blocking the exposed dentine tubules or reducing nerve activation associated with pain. These approaches can be incorporated into toothpastes or delivered separately in mouthwashes.
Blocking Exposed Dentine Tubules
Since the 1950s, Stannous Fluoride (SnF₂) has been used to reduce dentinal hypersensitivity by physically blocking dentine tubules. The stannous (tin) salt creates a deposit covered by a naturally forming dentinal smear layer, resistant to acids and water. SnF₂ is often combined with sodium hexametaphosphate, which helps remove dental stains – a common side effect of SnF toothpastes – due to its high affinity for pellicle proteins on enamel.
Used since the 19th century, strontium salts reduce sensitivity by forming strontium apatite complexes with dentine around the tubules. Combined with silica, they form an acid-resistant silica-strontium deposit.
The combination of Arginine and Calcium Carbonate forms a calcium and phosphate layer similar to dentine in and on top of the tubules, providing protection.
Calcium Sodium Phosphosilicate (CSPS) is known as bioglass and used since the 1970s as a bone-building agent, CSPS provides natural enamel building blocks. It forms a hydroxyapatite-like layer over and into dentine tubules, which is both acid and water-insoluble and resistant to mechanical removal by brushing.
Oxalates are composed of calcium and oxygen, oxalates react with calcium ions in saliva to form insoluble calcium oxalate crystals. They can be deposited into dentine tubules but are acid-soluble and can be washed away in low pH environments. Potassium or ferric salts are commonly used forms.
Reducing Nerve Activation
Potassium Salts (Nitrate, Chloride, Citrate) work by depolarizing the nerve fibres at the base of dentine tubules, preventing pain signal transduction. Pain signalling relies on a potassium gradient, with high concentrations inside the nerve fibre and low concentrations outside. Potassium salts equalise the levels inside and outside the nerve fibres, blocking the generation of pain signals.
Watch a video about the use of potassium nitrate in toothpastes to help with hypersensitivity: click here to view.
Stain removal /whitening ingredients in oral care products
Tooth whitening has become a significant industry, with three primary methods:
- Over-the-counter products for daily stain removal, such as toothpaste and mouthwash.
- Occasional use products like whitening strips or dental trays, available over-the-counter.
- Professional treatments using bleaching products in a dental clinic.
Abrasives
Whitening toothpastes often include stain-targeting abrasives and chelating agents. These abrasives may be harder and more concentrated than those in regular toothpastes, nearing the RDA limit of 250. Users with thinning enamel, receding gums, or exposed dentine should use these with caution to avoid increased tooth and tissue loss. Higher abrasivity toothpaste can remove more stains but may also strip away the enamel and dentine, especially at the gum line. Abrasive properties can be adjusted by altering size, shape, composition, and concentration, similar to the variety found in sandpaper.
Common abrasive ingredients:
- High stain removal: Perlite, alumina
- Medium stain removal: Hydroxyapatite, calcium pyrophosphate, hydrated silica
- Low stain removal: Sodium bicarbonate, calcium carbonate, brushite (dicalcium phosphate dihydrate)
Sodium bicarbonate (baking soda) is a long-used, mild abrasive with a slightly salty taste. Its small particles can reach areas missed by brushing, enhancing cleaning.
pigments
Blue covarine works by using its blue colour to counteract yellow stains, making teeth appear whiter without removing enamel. Enzymes like papain (from papaya) and bromelain (from pineapple) can break down the protein-based pellicle. Surfactants in most toothpaste/mouthwash products help remove light stains by eliminating hydrophobic compounds.
Stain prevention
Stain prevention agents like polyphosphates and sodium citrate help prevent calculus formation and bind chromogen ions from food and beverages. Polyphosphates include sodium/potassium pyrophosphate, sodium trimetaphosphate, and sodium hexametaphosphate. Calcium phosphates can adhere to enamel, preventing plaque formation and bacterial attachment.
Bleaching
Peroxide, allowed up to 0.1% in EU cosmetic toothpastes, is the most common bleaching agent in professional treatments. Forms include hydrogen peroxide (H₂O₂), calcium peroxide (CaO₂), sodium percarbonate (Na₂H₃CO₆), and magnesium peroxide (MgO₂). These work by oxidising organic chromogens, making them colourless. Professional treatments may combine H₂O₂ with light to speed up the oxidation process, potentially lightening teeth beyond their natural colour. A common side effect of bleaching is dentinal hypersensitivity, usually temporary.
Formulation of Oral Care Products
Toothpaste
Ingredient | Maximum concentration (% w/w) |
Sorbitol | 70 |
Abrasives | 55 |
Glycerin | 40 |
Insoluble metaphosphate (IMP) | 35 |
Ethanol (alcohol, alcohol denat.) | 30 |
Sodium pyrophosphate, potassium pyrophosphate | 15 |
PEG, PPG | 10 |
Oral care-protecting agents | 10 |
Anionic surfactants | 6 |
Thickeners | 5 |
pH stabilisers, vitamins, chelating agents | 5 |
Flavour | 3 |
Colourants | 2 |
Preservatives | 1 |
Antiplaque agents | 2 |
Sweetening agents | 0.5 |
Calcium glycerophosphate | 0.5 |
Fluoride compounds (calculated as fluorine) | 0.15 |
Water | To 100 |
Ingredient types and functions in toothpaste preparations
- Sorbitol – 70%
Sorbitol is a humectant which helps retain moisture and prevents toothpastes from drying out. It’s a carbohydrate which improves the rheology of products and has a pleasant sweet taste.
- Abrasives – 55%
Aids in removing plaque and stains from teeth surfaces. Examples include hydrated silica, dicalcium phosphate dihydrate, alumina, silicates and calcium carbonate.
- Glycerin – 40%
Similar to sorbitol, it helps keep the toothpaste moist as humectants ‘lock in moisture’.
- Insoluble Metaphosphate (IMP) – 35%
IMP is an abrasive agent which enhances the cleaning power by providing a gentle scrubbing action. An example of this is Sodium metaphosphate.
- Ethanol (alcohol, alcohol denat.) – 30%
Ethanol is used as a solvent and antibacterial agent in toothpastes. It helps dissolve other ingredients and provides some antibacterial properties.
- Sodium Pyrophosphate, Potassium Pyrophosphate – 15%
Sodium pyrophosphate and potassium pyrophosphate are tartar control agents
- PEG, PPG – 10%
These ingredients are humectants and surfactants, they help maintain moisture and improve texture. Polyethylene glycol and polypropylene glycol are common humectants in toothpaste.
- Oral Care-Protecting Agents 10%
Provides benefits such as antimicrobial action or sensitivity relief. Example: strontium chloride relieves pain and sensitivity by blocking fluid flow into dentinal tubules.
- Anionic Surfactants – 6%
Cleaning agents such as sodium lauryl sulfate (SLS) helps to create foam and remove debris.
Thickeners – 5%
Thickening agents provide the desired rheology (consistency). Examples: Xanthan gum, carrageenan and cellulose derivatives.
- pH Stabilisers, Vitamins, Chelating Agents – 5%
This group of ingredients ensures the product remains stable throughout its shelf-life. Examples: sodium hydroxide (pH adjuster), tocopheryl acetate (vitamin E), EDTA (chelating agent).
- Flavour – 3%
Flavouring ingredients such as botanical extracts can improve the sensory profile of toothpastes, especially when designed for children.Examples: mint, spearmint, peppermint.
- Colourants – 2%
Pigments are frequently used as part of the branding story, whites, blues and reds are most commonly used. Examples: Titanium dioxide, blue 1.
- Preservatives – 1%
Preservatives prevent microbial growth and extend shelf life. Examples: Sodium benzoate, methylparaben.
- Antiplaque Agents – 2%
These are active ingredients – which prevent the formation of dental plaque. Examples: zinc citrate, triclosan.
- Sweetening Agents – 0.5%
Sweeteners enhance the taste without promoting tooth decay (sugar-free). Examples: saccharin, xylitol, aspartame.
- Calcium Glycerophosphate 0.5%
Remineralising agent provides calcium ions to help remineralise teeth, forms a film on the surface of the teeth and prevents dental caries.
- Fluoride Compounds – 0.15% as fluorine
Fluoride ingredients strengthen tooth enamel and help prevent cavities. Examples: sodium fluoride, stannous fluoride.
- Water – to 100%
Water is the main solvent and ensures good rheology.
Mouthwash
Ingredient | Maximum Concentration (% w/w) |
Ethanol (alcohol, alcohol denat.) | 25 |
Humectants | 20 |
pH stabilisers, vitamins, chelating agents | 4 |
Emulsifying agents & surfactants | 4 |
Flavour | 3 |
Colourants | 3 |
Preservatives | 1 |
Deodorant | 0.5 |
Thickeners | 0.5 |
Sweetening agents | 0.2 |
Fluoride compounds (calculated as fluorine) | 0.1 |
Water | To 100 |
Ingredient types and functions in mouthwash preparations
- Ethanol (alcohol, alcohol denat.) – 25%
Solvent and antibacterial agent which helps dissolve other ingredients, provides antibacterial properties, and contributes to the mouthwash’s cleansing effect.
- Humectants – 20%
Humectants help leave a ‘moisturised’ feeling in the mouth after using a mouthwash as alcohol can be quite drying. Examples: glycerin, sorbitol.
- pH Stabilisers, Vitamins, Chelating Agents – 4%
This group of ingredients ensures the product remains stable throughout its shelf-life. Examples: sodium hydroxide (pH adjuster), tocopheryl acetate (vitamin E), EDTA (chelating agent).
- Emulsifying Agents & Surfactants – 4%
Emulsifiers are used to produce a homogenous mixture and surfactants help to remove any residue debris from the oral cavity. Examples: polysorbate 20, lecithin, PEG-60 hydrogenated castor oil, sodium lauryl sulphate (SLS), polysorbate.
- Flavour – 3%
Improves the taste of the mouthwash, making it more pleasant to use. Examples: peppermint oil, spearmint oil.
- Colourants – 3%
Colourants are added mainly as a marketing tool. Examples: blue 1, yellow 5.
- Preservatives – 1%
Preservatives prevent microbial growth and extend shelf life. Examples: sodium benzoate, methylparaben.
- Deodorant – 0.5%
Neutralises bad odours in the mouth, providing fresh breath. Examples: zinc gluconate, chlorhexidine, zinc chloride.
- Thickeners – 0.5%
Thickening agents provide the desired consistency and improve mouthfeel. Examples: xanthan gum, hydroxyethyl cellulose, cellulose derivatives.
- Sweetening Agents – 0.2%
Enhances the taste without promoting tooth decay (sugar-free) Examples: xylitol, sodium saccharin, aspartame.
- Fluoride Compounds (calculated as fluorine) – 0.1%
Strengthens tooth enamel and helps prevent cavities. Examples: sodium fluoride, stannous fluoride.
- Water (to 100%)
Water is the main solvent and ensures good rheology. This is the continuous phase of the mouthwash.
Breath Spray
Ingredients | Maximum Concentration (% w/w) |
Ethanol (alcohol, alcohol denat.) | 99 |
Humectants | 30 |
Flavour | 2 |
Deodorant | 0.5 |
Preservatives | 0.2 |
Sweetening agents | 0.2 |
Water | To 100 |
Ingredient types and functions in breath spray preparations
- Ethanol (alcohol, alcohol denat.) – 99%
Solvent and antibacterial agent which helps dissolve other ingredients, provides antibacterial properties.
- Humectants – 30%
Humectants help leave a ‘moisturised’ feeling in the mouth after using a breath spray as alcohol can be quite drying. Examples: glycerin, sorbitol, propylene glycol.
- Flavour – 2%
Improves the taste of the breath spray, making it more pleasant to use. Examples: peppermint oil, spearmint oil.
- Deodorant – 0.5%
Neutralises bad odours in the mouth, providing fresh breath. Examples: zinc gluconate, chlorhexidine, zinc chloride.
- Preservatives – 0.2%
Preservatives prevent microbial growth and extend shelf life. Examples: sodium benzoate, methylparaben.
- Sweetening Agents – 0.2%
Enhances the taste without promoting tooth decay (sugar-free) Examples: xylitol, sodium saccharin, aspartame.
- Water (to 100%)
Water is a solvent and ensures good rheology.
Regulation of Oral Care Products
Classification of oral care products
Toothpastes are not classified the same across the world due to the differing regulatory frameworks. Furthermore, the benefits and claims of the toothpaste can further determine the classification of the product.
Examples of therapeutic claims for toothpastes/oral care products include: removes plaque, treats tooth decay, repairs/prevents cavities.
Examples of non-therapeutic claims for oral care products include: whitening, freshens the breath, deep-cleanse toothpaste.
The below table outlines whether oral care products are cosmetics or non-cosmetics:
Region | Without Therapeutic Claims | With Therapeutic Claims |
EU | Cosmetic | Non-cosmetic |
UK | Cosmetic | Non-cosmetic |
USA | Cosmetic | Non-cosmetic |
Canada | Cosmetic | Non-cosmetic |
Australia | Cosmetic | Non-cosmetic |
Andean Community | Cosmetic | Non-cosmetic |
MERCOSUR | Cosmetic | Non-cosmetic |
China | Non-cosmetic | Non-cosmetic |
ASEAN | Cosmetic | Non-cosmetic |
In the USA, toothpastes can either be cosmetics or over the counter (OTC) products based on the ingredients they contain (fluoride containing toothpastes are non-cosmetics).
In Canada, toothpastes can be classified as cosmetics, natural health products and non-prescription drugs based on the ingredients in the formulation and claims made on pack.
In Australia toothpastes can be a cosmetic or a therapeutic goods product based on their ingredients and claims.
Fluoride in oral care products
The maximum concentration of fluoride is 0.15% or 1500 parts per million (ppm) according to the EU cosmetic regulation, however, it’s fluoride-containing ingredients which are added into cosmetics, not fluoride itself. Therefore, we have to calculate the amount of fluoride in fluoride containing compounds which are added into oral care formulations. The FDI World Dental Federation recommends brushing teeth twice daily for at least 2 minutes, especially before bed. According to Public Health England guidelines, to prevent caries, children aged 0-6 years should use a smear of toothpaste with at least 1000 ppm fluoride, while those aged 7 years and up, including adults, should use a pea-sized amount of toothpaste with 1350-1500 ppm fluoride.
Examples of fluoride containing ingredients permitted by the EU regulation:
- Sodium monofluorophosphate
- Potassium monofluorophosphate
- Calcium Fluoride
- Sodium fluoride
- Potassium fluoride
- Stannous fluoride
- Octadecenyl-ammonium fluoride
- Ammonium fluorosilicate
Finding the amount of fluoride in fluoride-containing ingredients
Calcium Fluoride (CaF₂) has a molecular weight of 78.074 u
Calcium has a molecular weight of 40.078 u
Fluorine has a molecular weight of 18.998 u
If we are adding 0.3% Calcium Fluoride into a toothpaste formulation, is this below the restriction threshold of 0.15% fluoride?
(18.998 x 2) / 78.074 x 100 = 48.66%
0.3 x 0.4866 = 0.14598% fluoride in formulation
0.14598% is below the 0.15% restriction threshold, therefore, it’s permitted in cosmetic formulations.
Labelling of oral care products
Oral care products frequently contain fluoride which does carry a health risk, therefore, it is important consumers are aware of the risk and appropriate directions of use are provided, especially to children.
For any toothpaste containing 0.1 to 0.15% fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory from 19th March 2009:
“Children of 6 years and younger: use a pea sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
The instructions for use should include “spit after use, do not swallow”.
Cosmetics Europe has published a guidance document about labelling of cosmetics, including toothpaste products, click here to view.
Abrasives in oral care products
All toothpastes must comply with acceptable abrasivity levels, an important factor when choosing a product. Abrasivity is assessed by relative dentine abrasivity (RDA), a lab test on natural tooth dentine, which can vary in hardness. Over-the-counter toothpastes should not exceed an ISO standard (ISO 11609 Tooth Relative Enamel Abrasivity and Relative Dentine Abrasivity Studies to Assess Oral Care Products) RDA value of 250. The effectiveness of an abrasive in removing pellicle and stains is measured by the pellicle cleaning ratio, which is determined through a similar mechanical test.
Claims of Oral Care Products
Claims of oral care products are frequently considered borderline claims due to their potential therapeutic actions. It is very important to ensure all claims for oral care products remain within the realm of cosmetics. All cosmetic claims must comply with the common claims criteria set out by the EU Commision.
Non-permitted claims
Tooth decay (or cavities), tooth wear and gum disease are considered adverse conditions, therefore products intended to ‘repair’ teeth/gums/enamel damaged by an adverse condition, or ‘fight’ against cavities already formed, will be considered medicines or medical devices depending on their mode of action.
Oral care products should only be marketed as preventatives to adverse effects, and claims to ‘keep the oral cavity in good condition & cleansing the oral cavity’ should be the main objectives of oral care products – and thus the claims should reflect this.
A reference to treating or preventing pain will be considered a medical claim. References to ‘sensitive formula’ or ‘suitable for sensitive teeth’ are acceptable for cosmetics. Chemical compounds can be incorporated into toothpaste formulations which reduce sensitivity, these are well established, documented and beneficial to public health.
Antimicrobial claims are not considered cosmetic claims, therefore, they should be avoided. Cleansing claims however, (such as ‘deep clean’), are permitted provided enough substantiation is provided for the claim.
permitted Claims
Teeth whitening/stain removal claims are acceptable as cosmetic claims as discoloured teeth are not an adverse effect. The product simply claims to change the appearance of the teeth.
Reference to cleansing is permitted, as long as the reference is not to cleansing away/removing plaque or other dental issues.
Claims which state that teeth will be protected and kept in good condition are permitted as this is the main role of oral care products. Reference to the removal of day-to-day grime is permitted as long as the ‘grime’ is not specified to be anything related to dental problems.
Substantiation Challenges of oral care products
Sensitivity claims are difficult to substantiate because pain is challenging to measure consistently. Its intensity and type can vary throughout the day; for example, a tooth might be sensitive in the morning but less so later, or react differently to cold air at noon and a toothbrush at night. Pain is also influenced by emotional factors, which can alter the perception of pain during a clinical trial.
To address these issues, anti-sensitivity studies acknowledge the possibility of a placebo effect, where participants feel pain relief simply because they believe they are receiving treatment, and the Hawthorne effect, where behaviour changes due to being observed. To mitigate these effects, studies include laboratory tests to demonstrate the physical efficacy of anti-sensitivity materials, use multiple types of pain stimuli, incorporate both participant and independent observer ratings, and require a threshold level of pain reduction to be met.
Abrasive toothpastes are tested on real teeth, but the issue with this is that each tooth has a different relative hardness, so many repeats have to be conducted in order to get viable results.
Currently, there is insufficient scientific evidence to support significant claims about charcoal toothpastes, whether for cosmetic purposes (stain removal/whitening) or therapeutic benefits (antimicrobial action, caries reduction). This lack of evidence stems from a shortage of adequate clinical trials demonstrating that charcoal-containing products are superior to those without charcoal. Additionally, because charcoal is a relatively new or trendy ingredient in commercial toothpastes, there is less information available about its effects.
The Cosmetics, Toiletries and Perfumery Association (CTPA) has published a guidance document on oral care product claims, click here to view.
