
Oral care
Teeth whitening gel OEM/ODM manufacturing
Teeth Whitening Gel · Stain Removal Gel · OEM/ODM
Teeth whitening is in high demand, but it is also an oral care category with very clear legal boundaries. Whitening products sold directly to consumers may contain or release no more than 0.1% hydrogen peroxide; higher concentrations may only be supplied through dentists or applied by a dentist. Cosmetic teeth whitening gels therefore follow three routes: removing stains on the enamel surface, creating an optical effect that makes teeth look whiter, and using peroxide at the permitted level. Claims must match the mechanism — saying exactly what the product does. Butter-C offers full-service OEM/ODM manufacturing, from formula to labeled finished product with its notification dossier.
Formula base
A brushing or applied gel with stain-removing actives
Teeth whitening gel is usually a clear gel or a gel with fine particles, used like a toothpaste or applied to the tooth surface and then rinsed off.
Gelling agents
Cellulose gum, carbomer, xanthan — a clear gel that adheres to the tooth surface just enough.
Stain removal
Polyphosphates and pyrophosphates bind to stains; low-abrasion silica; papain enzyme.
Optical effect
Blue pigment CI 74160 forms a very thin layer that temporarily makes teeth look whiter.
Peroxide at the permitted level
Hydrogen peroxide or a peroxide-releasing compound at a maximum of 0.1% for products sold directly to consumers.
Key technical points
Four factors that define teeth whitening gel quality
Within the peroxide limit
Total peroxide present or released does not exceed 0.1%, quantified on the finished product both at production and after aging.
Low abrasion
Stains are removed chemically (polyphosphates) rather than by increasing abrasiveness, so enamel is not worn down with long-term use.
Active stability
Polyphosphates hydrolyze easily and peroxide breaks down easily in high-water bases — this calls for a low-water base, suitable pH and suitable packaging.
Claims that match the mechanism
"Removes stains", "looks whiter" — no promise to change the color of the enamel.
Three formulation directions
Three common teeth whitening gel lines
Stain-removing brushing gel
Polyphosphates, low-abrasion silica, optional fluoride; used daily in place of toothpaste.
Optical gel
Blue pigment CI 74160 with a cleaning system; teeth look whiter right after brushing.
Applied gel with peroxide at the permitted level
Hydrogen peroxide at a maximum of 0.1%, as a pen or a gel with trays; the label states the concentration and warnings clearly.
Concentrations above 0.1%
Supplied only through dentists, not sold directly to consumers — discussed separately, outside the scope of retail products.
Parameters we monitor
What our R&D lab measures on every sample
These are the parameters Butter-C monitors while developing the formula and scaling it up to production. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- Peroxide content
- Peroxide present or released is quantified at production and after aging.
- Polyphosphate content
- Hydrolysis is tracked over time.
- Abrasiveness
- Low-abrasion abrasives per the supplier's specification sheet; assessed when making claims.
- pH, viscosity
- Measured on the gel and on a diluted solution.
- Color
- Blue pigment stability, no separation.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Packaging compatibility
- Tube swelling from peroxide gas and delamination of the tube lining are monitored.
Claims
Writing claims within the cosmetic scope
This is an oral care category where claims very easily overreach. Butter-C reviews the wording on the label and marketing materials as soon as the notification dossier is prepared.
Removes coffee and tea stains
Instead of: bleaches teeth.
Helps teeth look whiter
Instead of: whiter teeth in 7 days, 3 shades whiter.
Teeth look whiter right after brushing (products with blue pigment)
Clearly stated as a temporary effect.
Helps reduce stain build-up
Instead of: removes tartar, at-home tartar removal.
Warning for products containing peroxide
"Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them."
Directions
State the amount, duration and number of uses per day; do not swallow.
Manufacturing specifications
Current capabilities
- Textures
- Clear gel, gel with fine particles, light blue gel.
- Formats
- Multilayer plastic tubes, applicator pens, gel syringes with trays. Net weight is agreed when choosing packaging.
- Minimum order quantity
- Agreed per order and per flavor.
- Testing
- Performed at a GLP / ISO 17025-accredited laboratory, including peroxide quantification where applicable; a certificate of analysis is delivered with each batch.
- Documentation
- The Product Information File (PIF) and the notification dossier are prepared by Butter-C.
- Packaging
- Label design, printing and packing run in parallel with formula development.
Suggested product concept
Polyphosphate and blue pigment whitening brushing gel
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed to match your brand positioning and price range.
Polyphosphates
Remove coffee and tea stains; help reduce stain build-up.
Optical blue pigment
Teeth look whiter right after brushing.
Low abrasion
For daily use in place of toothpaste.
50 g tube
Light blue mint gel; the carton clearly explains the mechanism and directions.
Customization options
What you can specify
The same product type can serve very different customer groups depending on the brand. Tell us your requirements in the areas below and our team of pharmacists will develop a matching formula.
Mechanism
Stain removal, optical, peroxide at the permitted level, or a combination.
Fluoride
With or without fluoride for brushing gels.
Flavor
Mint, mild mint, cinnamon, fruit.
Format
Brushing gel, applicator pen, gel with trays.
Hero ingredients
Papaya enzyme, activated charcoal, hydroxyapatite.
Packaging
Tubes, applicator pens, regimen kits with trays.
Further reading
Related topics
Toothpaste manufacturing
Abrasives, fluoride and toothpaste bases.
Herbal toothpaste manufacturing
Bamboo charcoal, salt and how to talk about stain removal.
Cosmetic labeling rules
Mandatory warnings for products containing peroxide (in Vietnamese).
The cosmetic PIF
Safety assessment for oral care products (in Vietnamese).
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details (in Vietnamese) →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
Head office: Huu Le village, Dai Thanh commune, Hanoi · Factory: Thanh Oai Industrial Cluster, Binh Minh commune, Hanoi, Vietnam
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