BUTTER-C
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Cetylpyridinium chloride (CPC) mouthwash OEM/ODM manufacturing
Cetylpyridinium Chloride (CPC) Mouthwash · OEM/ODM
Cetylpyridinium chloride (INCI: Cetylpyridinium Chloride; CPC) is a positively charged quaternary ammonium compound — a water-loving pyridinium head attached to an oil-loving 16-carbon chain — used mainly in mouthwashes and some toothpastes. Dental trials of complete mouthwashes containing 0.05–0.1% CPC, used in addition to toothbrushing, report small benefits on research indices, with low to moderate certainty and a strong dependence on the formula; that is research context, while the cosmetic claims stop at cleaning the mouth and fresh breath. What sets a CPC mouthwash apart from a generic one is the chemistry of a cationic ingredient: CPC is inactivated by anionic surfactants and polymers, and heavy use of nonionic solubilizers can hold CPC inside micelles and reduce the available fraction. On the regulatory side, CPC is not named in ASEAN Annexes II, III, VI or VII, so it does not count as a preservative — the formula still needs a challenge-tested Annex VI preservative system. Butter-C offers full-service OEM/ODM manufacturing of CPC mouthwash, from formulation, CPC assay in the finished product and sensory testing to a labeled product and its notification dossier.
Formula base
CPC in a water – polyol base, nonionic solubilizers and a separate preservative system
CPC makes up only about one part per thousand of the weight; the rest of the formula decides whether CPC stays available or is "locked up" by other ingredients.
Cetylpyridinium Chloride: raw material and COA
CAS 123-03-5 (anhydrous, C₂₁H₃₈ClN, 340.0 g/mol) or 6004-24-6 (monohydrate, 358.0 g/mol) according to PubChem. According to the SCCS dossier (2015), CPC is freely soluble in water (50 g/L at 19.5 °C), a 10 g/L solution has a pH of 6–7, it melts at 77–83 °C, is stable under normal storage and decomposes at about 130 °C. CPC is in Butter-C's existing ingredient list; the COA must state anhydrous or monohydrate so the content is converted correctly.
Water – polyol base
Glycerin and Sorbitol give a light sweetness and moisture; Propylene Glycol helps dissolve the flavor. The alcohol line uses Alcohol as on the general mouthwash page; the alcohol-free line follows the alcohol-free mouthwash page.
Nonionic solubilizers, kept to the minimum for clarity
Mint flavor and menthol need a nonionic solubilizer (poloxamer, PEG hydrogenated castor oil). According to Butter-C's CPC article, large amounts of solubilizer can hold CPC inside micelles and reduce the available fraction; the effect differs between solubilizers (Robertson et al., 2024 — in vitro, authors and funding from industry). The solubilizer is therefore set at the lowest level that keeps the solution clear.
Taste, pH and preservative system
CPC tastes slightly bitter (practical experience) → Xylitol, Sodium Saccharin, Sucralose and mint flavor mask it. Citric Acid – Sodium Citrate hold the pH. Preservation with Sodium Benzoate (Annex VI Ref 1: oral care products up to 1.7% as acid) and Potassium Sorbate (Ref 4: up to 0.6% as acid); these are anionic preservatives, so their interaction with CPC is re-assessed on the actual formula.
Key technical points
A cationic ingredient, available fraction, regulatory status and safety
These five points are where a CPC mouthwash differs from a generic mouthwash.
No anionic ingredients alongside
Per the combination table in Butter-C's CPC article: avoid anionic surfactants (SLS, sarcosinate) and anionic polymers (carbomer, cellulose gum, xanthan) in the same formula, because cationic ingredients are inactivated by anionic components (background knowledge from the oral care formulation chapter; the PubMed sources read have not quantified the loss due to SLS alone). Plant practice: check equipment rinse water so that no anionic detergent residue gets into the batch; some anionic colorants also need testing.
Total assay is not enough: the available fraction matters
According to the source article, results of CPC mouthwashes depend on the formula (Gunsolley, 2006 — meta-analysis of 6-month trials). Butter-C assays total CPC in every finished batch and, when the formula has many excipients, considers an additional availability test; changing the solubilizer, flavor or preservative means a new formula.
Not a preservative under ASEAN rules
Searched by name and CAS 123-03-5, 6004-24-6, CPC is not named in Annexes II, III, VI (release 2026-1) or VII (release 2025-2). The quaternary ammonium entries in Annex VI are other substances: Ref 44 (alkyl C12-22 trimethyl ammonium bromide and chloride, 0.1%), Ref 53 (benzethonium chloride, 0.1%), Ref 54 (benzalkonium, 0.1% as benzalkonium chloride). Not being named does not mean "no limit": its oral care role needs confirmation by regulatory staff for the target market and a safety dossier.
SCCS levels are EU-related, not ASEAN limits
The SCCS (2015) assessed CPC in a dossier proposing it as a preservative in the EU: mouthwash 0.1%, other oral hygiene products 0.5%, lotions and creams 0.2%, non-spray deodorants 2.0%; it concluded that, except for potential skin, eye and oral mucosal irritation, CPC in a single cosmetic product at these levels is safe for consumers. The opinion covers non-spray products only; CPC has high acute inhalation toxicity in rats → Butter-C does not make CPC breath sprays without a separate safety assessment.
Tooth staining and how it feels in the mouth
After 3 and 6 months of a 0.07% CPC mouthwash, stain scores differed slightly but significantly from the control group (Van Leeuwen et al., 2015); compared with chlorhexidine, CPC tends to stain less (Windhorst et al., 2025). CPC-specific rates of taste change or mucosal burning are not given in the abstracts read → sensory and tolerance testing on the finished product. Worker safety: ECHA notifications for CPC include H330 (fatal if inhaled) and H318 (serious eye damage) → weigh the powder with a dust mask, goggles and gloves.
Three formulation directions
Three CPC mouthwash lines
Alcohol-free CPC, mild mint
CPC at the levels used in trials (0.05–0.1%) in a glycerin – sorbitol base, menthol and mint flavor with just enough solubilizer; a base line for daily use. The technical base follows the alcohol-free mouthwash page; this page adds what is specific to CPC.
CPC – zinc for a fresh-breath positioning
Adds zinc gluconate, a water-soluble zinc salt under Annex III Ref 24, total zinc up to 1% calculated as zinc. The source article notes that zinc salts can be combined with CPC; the evidence for each ingredient is considered separately, and "fresh breath" is a claim for the whole product, backed by testing. Zinc's astringency is masked with polyols and flavor.
CPC with alcohol, strong cooling, for adults
Alcohol dissolves the flavor and gives a clear cooling feel; storage and filling follow rules for flammable goods, a cap that is hard for children to open, positioned for adults. The SCCS notes that oral mucosa irritation tests in animals with CPC mouthwashes generally showed little or no effect, and considered that alcohol or other components may be the cause when irritation occurred → tolerance testing on the finished product.
Packaging is designed with the formula
PET bottles with a dosing cap, travel bottles, single-use sachets. Stability studies are run in the real packaging with CPC assay (the source article recommends stability studies that assay CPC in the finished product); caps and seals are tested with the flavor system.
Parameters we monitor
What our R&D lab measures on every sample
These are the parameters Butter-C monitors during formula development and scale-up. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- Incoming CPC COA
- INCI, CAS (anhydrous or monohydrate), purity per the supplier's COA; weighed amount converted according to the form.
- CPC content in the finished product
- Assayed in every batch, fresh and after accelerated aging in the real packaging; reported as % CPC.
- Available fraction (when the formula has many excipients)
- An availability test proposed by the testing laboratory, repeated when the solubilizer, flavor or preservative changes.
- pH and clarity
- Measured fresh and after aging; observed at cold, room and elevated temperature — haze signals flavor beyond the solubilizing capacity or an incompatibility.
- Zinc content (zinc line)
- Total zinc from all zinc salts not above 1% calculated as zinc (Annex III Ref 24).
- Ethanol
- Alcohol line: assayed. Alcohol-free line: absence of ethanol confirmed, including any carried in with the flavor, before "alcohol-free" goes on the label.
- Preservative efficacy and microbiology
- Preservative challenge test to ISO 11930 on the final formula — CPC is not counted as a preservative; microbiology at a GLP/ISO 17025 laboratory.
- Sensory and tolerance
- Trial rinsing for bitterness, cooling and aftertaste; staining, taste change and mucosal burning are recorded over several days of use if you commission an in-use test.
Claims
Claims for a CPC mouthwash
A mouthwash is a cosmetic. Appendix 03-MP of Circular 06/2011/TT-BYT lists, for oral hygiene and care products, claims that are not accepted, such as preventing "dental abscess, gum swelling, gingivitis, mouth ulcers, periodontal disease, pus around the teeth, palate inflammation, misaligned teeth, oral infections". The data on CPC are dental data on complete mouthwashes used in addition to toothbrushing, measuring plaque and gingival indices: a review by Haps et al. (2008, 8 publications) reports a small but significant added benefit; a meta-analysis of 72 trials by Figuero et al. (2026) rates certainty versus placebo as low to very low at 3 months and low at 6 months; with toothbrushing, CPC 0.05–0.1% did not differ significantly from chlorhexidine 0.12–0.2% (Windhorst et al., 2025 — with an unrestricted educational grant from a company); results were heterogeneous and formula-dependent (Gunsolley, 2006). For breath, data on CPC alone are limited: in 13 people, CPC 0.025% was no better than water at hours 2 and 3 (Young et al., 2003). This is research context and does not become a claim. Butter-C reviews label and promotional wording when preparing the notification dossier.
Helps keep breath fresh (whole product, tested)
Instead of: drug-like promises to end bad breath, claims to act on odor-causing bacteria.
Cleans the mouth, used in addition to toothbrushing
Instead of: replacing brushing and interdental cleaning, percentages of bacteria removed, plaque or gum claims borrowed from dental studies.
Contains cetylpyridinium chloride (CPC) — ingredient description
Instead of: turning the functions declared on CosIng into benefits, "self-preserving", "no preservative needed".
Daily oral care
Instead of: drug-like claims about caries, gums, mouth ulcers or periodontal disease; "prevents cavities" (CPC is not fluoride); claims about viruses or "throat protection".
With or without alcohol (ingredient description)
"Alcohol-free" only once it is confirmed that the flavor and other raw materials carry no ethanol.
Directions and cautions
Rinse and spit, do not swallow; use in addition to toothbrushing; keep out of reach of children — not for children who cannot yet rinse and spit (Butter-C's cautious practice). May cause slight surface staining of teeth with long-term use; if staining is marked, taste change persists or the mouth feels sore, stop and ask a dentist. Pregnancy or breastfeeding: not enough human data, ask a doctor. Instead of: "no staining", "non-irritating", "safe for pregnant women and children".
Manufacturing specifications
Available capabilities
- Texture
- Clear solution, colorless or colored (colorants tested for compatibility with CPC).
- Ingredients
- Cetylpyridinium chloride, zinc gluconate, xylitol, menthol and peppermint oil are in Butter-C's existing ingredient list.
- Pack formats
- PET bottles with a dosing cap, travel bottles, single-use sachets. Volume agreed when packaging is selected.
- Minimum order quantity
- Agreed per order and per flavor.
- Testing
- Performed at a GLP/ISO 17025 laboratory, including CPC assay; results delivered with every batch.
- Documentation
- Product information file (PIF) and notification dossier prepared by Butter-C, with the CPC COA and a safety assessment that accounts for aggregate exposure.
- Packaging
- Label design, printing and packing run in parallel with formula development.
Suggested product concept
Alcohol-free CPC – zinc mouthwash, mint flavor
A concept to help you picture the product, not a ready-made product for sale. The actual formula is built around your brand positioning and price range.
Cetylpyridinium chloride
At the levels used in mouthwash trials (0.05–0.1%); CPC assayed in every batch and after aging.
Zinc gluconate
For the fresh-breath positioning, total zinc within Annex III Ref 24.
Alcohol-free, mild mint
Menthol and peppermint oil with a nonionic solubilizer at the lowest level that keeps it clear; xylitol and sucralose mask bitterness and astringency.
500 ml bottle with dosing cap
Label: rinse and spit, do not swallow; use in addition to toothbrushing; keep out of reach of children.
Customization options
What you can specify
The same product type can target very different customers. Tell us your requirements in the areas below and our pharmacists will build the formula accordingly.
With or without alcohol
Decides the cooling intensity, the solubilizer system, storage conditions and target users; for the alcohol-free line see also the alcohol-free mouthwash page.
CPC level
Within the range used in trials (0.05–0.1%); set by taste and assay results, without borrowing study data from other products.
Combined ingredients
Zinc gluconate (total zinc per Ref 24), xylitol, menthol, peppermint oil — the evidence for each is considered separately; no anionic surfactants or polymers.
Color and flavor
Colorless or colored; strong mint, mild mint or herbal — each choice re-tests clarity and CPC in the finished product.
Other products in the line
A CPC toothpaste needs a non-anionic foaming system and separate testing; breath sprays do not use CPC without a separate safety assessment (the SCCS opinion covers non-spray forms only) — alternatives: zinc salts, mint flavor.
Further reading
Related knowledge
Cetylpyridinium chloride (CPC) in mouthwash
Dental evidence read within its scope, the combination table, the SCCS conclusion and ASEAN status (in Vietnamese).
Mouthwash manufacturing
The general technical base for mouthwash; this page focuses on CPC.
Alcohol-free mouthwash manufacturing
Solubilizer and preservative systems for the alcohol-free line.
Xylitol mouthwash manufacturing
A line that can include CPC or zinc, with xylitol for a mild sweetness.
Zinc citrate in cosmetics
A zinc salt often used with CPC and how total zinc is calculated (in Vietnamese).
An oral care routine
Mouthwash is an extra step and does not replace brushing (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 →
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).
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