Close-up of a smile with white teeth

Oral care

Teeth whitening gel OEM/ODM manufacturing

Teeth Whitening Gel · Stain Removal Gel · OEM/ODM

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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).

Công ty cổ phần Dược mỹ phẩm Butter-C · Business registration no. 0108681386 (Hanoi Department of Planning and Investment, 03/04/2019)
Head office: Huu Le village, Dai Thanh commune, Hanoi · Factory: Thanh Oai Industrial Cluster, Binh Minh commune, Hanoi, Vietnam
Hotline +84 987 964 764 · [email protected] · Privacy policy
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