BUTTER-C
Oral care
Chlorhexidine mouthwash OEM/ODM manufacturing
Chlorhexidine Mouthwash · Chlorhexidine Oral Rinse · OEM/ODM
Chlorhexidine mouthwash is familiar to dental clinics and is usually recommended by dentists for a short period. The first thing you need to know: when chlorhexidine is used as the active ingredient for an oral antiseptic purpose, the product is regulated as a drug and cannot be notified as a cosmetic. In cosmetics, chlorhexidine is permitted only as a preservative at very low levels. For this reason, the manufacturing approach, registration dossier and facility requirements for this product are discussed separately for each project. If you need a retail mouthwash that follows the cosmetic dossier route, Butter-C can advise on alternatives with CPC, zinc salts or herbal ingredients.
Formula base
An aqueous solution with chlorhexidine and compatible supporting ingredients
A chlorhexidine mouthwash formula is simple in composition but demanding in terms of compatibility, because chlorhexidine loses its effect when it meets many common oral-care ingredients.
Active ingredient
Chlorhexidine digluconate, at the level stated in the registration dossier.
Solvent and humectants
Purified water, glycerin, sorbitol; with or without alcohol.
Flavor solubilizers
Nonionic solubilizers such as poloxamer and PEG-40 hydrogenated castor oil.
Taste
Mild mint flavor and non-cariogenic sweeteners to mask the bitterness.
Key technical points
Four factors that define a chlorhexidine product
Avoiding ingredients that deactivate it
No SLS, soaps or anionic surfactants; caution with certain colorants and negatively charged polymers.
Active content as stated in the dossier
Chlorhexidine is assayed in every batch, at manufacture and after aging.
Masking bitterness
Chlorhexidine is bitter and can temporarily alter taste perception; flavor and sweeteners are finalized on rinse-tested samples.
Label and directions
Label content, duration of use and warnings (tooth staining with prolonged use, do not swallow) follow the registration dossier.
Three formulation directions
Two directions by product category and one cosmetic alternative
Chlorhexidine mouthwash for the dental channel
Active ingredient per the drug dossier; supplied through clinics and pharmacies.
Alcohol-free version
Gentler for users during a short course; requires suitable solubilizers and a suitable preservative system.
Cosmetic alternative
CPC, zinc salt or herbal mouthwash — claims of keeping breath fresh and helping limit plaque.
Packaging is planned with the formula
Dark, light-blocking bottles with measuring caps; materials that do not absorb the active.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters monitored during formula development. Parameters for the registration dossier are applied according to the regulations for this product category.
- Chlorhexidine content
- Assayed at manufacture and after aging.
- pH
- Measured after manufacture and after aging; affects the stability of the active.
- Clarity, color
- No haze, no precipitate, no color change under light.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Packaging compatibility
- Absorption of the active into the bottle and cap leakage are tracked.
- Sensory profile
- Taste and aftertaste after rinsing, compared with the reference sample.
Claims
Claims that match the product category
The claims on the label determine which category the product falls into. Products containing chlorhexidine as the active ingredient state claims according to the registration dossier; the cosmetic alternative uses cosmetic wording only.
Products containing chlorhexidine
Indications, dosage and duration of use are stated according to the registered dossier.
Cosmetic alternative: keeps breath fresh
Instead of: oral antiseptic, treats bad breath.
Cosmetic alternative: helps limit plaque
Instead of: kills 99.9% of bacteria.
Cosmetic alternative: gum care
Instead of: treats gingivitis, periodontitis, after tooth extraction.
General directions
Rinse and spit out, do not swallow; keep out of reach of children.
User note
Prolonged use may stain the tooth surface — stated according to the dossier.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear solution.
- Format
- Dark bottle with measuring cap. Volume agreed during packaging selection.
- Product category
- Products containing chlorhexidine as the active ingredient are regulated as drugs — not covered by the cosmetic product notification.
- Manufacturing and registration
- Manufacturing requirements and the registration dossier are discussed separately for each project.
- Cosmetic alternative
- CPC, zinc or herbal mouthwash: the PIF and cosmetic product notification are prepared by Butter-C.
- Minimum order quantity
- Agreed per order.
Suggested product concept
A product pair for the dental and retail channels
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed according to the dossier category selected.
Dental channel
Alcohol-free chlorhexidine mouthwash, used as directed by a dental professional, with its own dossier.
Retail channel
Cosmetic mouthwash with CPC and zinc for daily use.
Shared design
Both products share the brand identity, with labels that clearly distinguish the product category.
Dark 250 ml bottle
Measuring cap, label with clear directions.
Customization options
What you can specify
Within the same product type, each brand targets a different customer group. Tell us your requirements in the areas below, and our team of pharmacists will advise on a matching solution.
Dossier category
Product containing chlorhexidine (separate dossier) or the cosmetic alternative.
With or without alcohol
Alcohol-free is gentler.
Flavor
Mild mint, strong mint.
Sales channel
Dental clinics, pharmacies, retail.
Documentation
An existing registration number, or a new registration required.
Packaging
Dark bottles, travel-size bottles.
Further reading
Related topics
Mouthwash manufacturing
Cosmetic options with CPC, zinc and herbal ingredients.
Alcohol-free mouthwash manufacturing
An alcohol-free cosmetic option with a mild taste.
Saline mouth rinse manufacturing
A familiar oral hygiene product.
Cosmetic labeling rules
How cosmetic labels differ from other product categories (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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