BUTTER-C
Signature ingredients
Clove mouthwash OEM/ODM manufacturing
Clove Mouthwash · Clove Bud Oil Mouth Rinse · OEM/ODM
Clove is familiar in traditional oral care and appears in dentistry (eugenol in temporary filling materials), so a mouthwash named for clove earns trust easily. In cosmetics, clove bud oil is first of all a fragrance and flavor ingredient: CosIng classifies Eugenia Caryophyllus Flower Oil as a fragrance, consisting chiefly of eugenol, which gives a warm, spicy taste. The “benefit” data for clove come from other settings: one dental trial used a self-made clove gel applied to the oral mucosa before needle insertion (Alqareer 2006), and two lab studies gave inconsistent results — none tested a mouthwash at flavoring level. What actually drives the formula is regulation: methyleugenol, an impurity naturally present in the oil, is limited to 0.0002% in oral hygiene products (ASEAN Annex II, Ref 451), so the oil level must be calculated from each lot's methyleugenol certificate and added up with every other fragrance source. Unlike the general alcohol-free mouthwash page and the oral care essential oil page, this page covers what is specific to clove: the methyleugenol calculation, the plant part on the COA, fragrance allergens for EU export, claim limits, and the reminders not to swallow and to keep out of reach of children. Butter-C offers turnkey OEM/ODM manufacturing, from formula development and testing to labeled finished goods and the notification dossier.
Formula base
Clove bud oil at flavoring level in an alcohol-free mouthwash base
Clove oil makes up only a tiny share of the formula; the rest is an alcohol-free mouthwash base with polyols, solubilizers, breath-freshening ingredients and a challenge-tested preservative system.
Clove bud oil
INCI Eugenia Caryophyllus Flower Oil — CosIng: the volatile oil steam-distilled from dried clove flower buds, which “consists chiefly of eugenol”; function: fragrance. The material in our ERP is registered as “Eugenia Caryophyllata Essential Oil”, which is not a CosIng INCI name. Bud, leaf and stem oils share CAS 84961-50-2, so the COA must state the plant part for the label to carry the right INCI (bud → Flower or Bud Oil; leaf → Leaf Oil). No use concentration has been established: CIR has no report on clove or eugenol (checked 16/10/2026, per our clove oil article).
Polyols, solvents and solubilizers
Purified water; glycerin, sorbitol or xylitol for moisture and mild sweetness; propylene glycol to aid solubility. Eugenol dissolves in water at about 2,460 mg/L at 25 °C and is miscible with alcohol and oils (PubChem) — the oil is premixed into the flavor system or a nonionic solubilizer (PEG-40 hydrogenated castor oil, polysorbate 20) before it goes into the water phase (practice, validated on the formula).
Breath-freshening ingredients
Zinc gluconate (Annex III Ref 24: water-soluble zinc salts max 1% as zinc) or cetylpyridinium chloride (CPC). “Fresh breath” is a claim for the whole product, backed by testing — not a claim for clove oil.
Taste, pH and preservation
Low-dose menthol for coolness, mint flavor (it must come with a methyleugenol declaration), sucralose if more sweetness is needed; citric acid – sodium citrate to hold pH; sodium benzoate (Annex VI Ref 1: oral care products max 1.7% as acid) and potassium sorbate (Ref 4: max 0.6% as acid). Essential oils are not preservatives: the preamble to Annex VI notes that many essential oils have antimicrobial properties but “are not included in the ANNEX”.
Key technical points
Methyleugenol, adding up sources, plant part and mucosal irritation
These are the points where a clove mouthwash differs from an ordinary alcohol-free mouthwash; each is settled with raw-material certificates, a calculation sheet and testing on the sample.
Methyleugenol sets the maximum oil level
ASEAN Annex II, Ref 451 prohibits methyleugenol “except for normal content in the natural essences used”, with finished-product caps that include “(e) 0.0002 % in other leave-on products and oral hygiene products”. Even though a mouthwash is spat out, it falls under this 0.0002% cap, not the 0.001% cap for rinse-off products. An EFSA 2023 dossier measured 0.039–0.128% methyleugenol in seven lots of clove bud oil — data for those lots, not representative of every supplier, so there is no single figure that fits every lot.
The calculation, adding up every source
Maximum oil (%) = 0.0002 ÷ methyleugenol in the oil (%) × 100, rounded down: a lot with 0.128% → max 0.15%; a lot with 0.039% → max 0.51%. If mint flavor or other oils are used, subtract their methyleugenol first. Illustrative example (not a measured lot): a flavor at 0.15% with a declared 0.02% methyleugenol contributes 0.00003%; the remaining 0.00017% divided by a 0.128% clove lot → max 0.13% oil. Recalculate whenever the lot or flavor changes; the level actually used is usually below the cap because of the hot, spicy taste.
Eugenol, isoeugenol, methyleugenol — three different substances
Eugenol (CAS 97-53-0) and isoeugenol (CAS 97-54-1) are not listed in ASEAN Annexes II, III, VI or VII; methyleugenol (CAS 93-15-2) is the substance of Ref 451. Eugenol is a fragrance allergen: ASEAN has no labeling threshold (Annex III leaves entries 67–92 blank); goods for the EU name “Eugenol” (Regulation 1223/2009, Annex III entry 71) and “Eugenia Caryophyllus Oil” (Regulation 2023/1545, entry 356) above 0.001% in leave-on or 0.01% in rinse-off products, based on the supplier declaration. The IFRA limit for eugenol in the toothpaste and mouthwash category is 1.5% of the finished product — a voluntary fragrance-industry standard.
Mucosal irritation, stability, handling safety
Eugenol in contact with oral soft tissue can cause local irritation and cytotoxicity (Sarrami 2002, dental-material setting) — the oil is used only at flavoring level, with the heat set on tasting samples. Eugenol “darkens and thickens on exposure to air” (PubChem) → raw material kept full, sealed and away from light; finished product monitored for color. EFSA considers clove oils irritant to skin, eyes and the respiratory tract and skin sensitizers → gloves, goggles and ventilation when weighing.
Three formulation directions
Three clove mouthwash lines
Clove – zinc, mild mint
Zinc gluconate, clove bud oil, low-dose menthol; warm first, cool after. The astringency of zinc is masked with polyols and flavor.
Clove – mint – CPC
CPC for a fresh-breath positioning, stronger mint flavor. CPC is not combined with anionic surfactants or anionic polymers; nonionic solubilizers are used only as much as clarity requires. The mint flavor goes into the methyleugenol calculation.
Clove – xylitol, menthol-free
For people who like a warm taste without coolness: xylitol and sorbitol give mild sweetness, clove oil is the main scent; with no dedicated breath ingredient, the breath claim needs more thorough testing; the label reminds users to keep it away from pets (xylitol, per the xylitol mouthwash page).
Packaging is planned with the formula
Opaque or tinted light-protective PET bottles with dosing caps; travel bottles, single-use sachets. A child-resistant cap is worth considering. Gaskets and closures are compatibility-tested with the oil.
Parameters we monitor
What our R&D team measures on every sample
Below are the parameters Butter-C monitors during formula development and scale-up to production. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- Incoming essential oil COA
- Each lot: INCI, plant part, eugenol, eugenyl acetate (helps tell bud oil from leaf oil per the specifications in the EFSA dossier), methyleugenol, refractive index, density.
- Methyleugenol calculation sheet
- From the oil level, the COA and declarations for other flavors; the finished-product total stays within 0.0002% (Annex II Ref 451); kept in the PIF.
- pH and clarity
- Measured when freshly made and after aging; observed at cold, room and high temperature — haze signals that oil or flavor exceeds the solubilizer's capacity.
- Key ingredient content
- Zinc or CPC assayed in the finished product (CPC: the available fraction when solubilizers are present).
- Ethanol
- Confirmation of no ethanol, including any carried in by flavors, before claiming “alcohol-free”.
- Preservative efficacy
- ISO 11930 challenge test on the final formula; essential oils are not counted as preservatives.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Color, odor, taste and packaging
- Stable after aging, with and without light; tasting panel for heat, coolness and aftertaste; flavor absorption into the bottle, cap leakage.
Claims
Claims for a clove mouthwash
Mouthwash is a cosmetic. Appendix 03-MP of Circular 06/2011/TT-BYT (the ASEAN cosmetic claims guideline) does not accept claims to prevent or address dental abscess, gumboils, gingivitis, mouth ulcers, periodontal disease, pus around the teeth, inflammation of the palate or other oral infections; a “numbing effect” is also on the unacceptable list (skin products section). Dental and lab data on clove are not a basis for claims. Butter-C reviews the wording on the label and in marketing materials when preparing the notification dossier.
Clove flavor, warm and spicy; helps keep breath fresh (whole product, tested)
Instead of: toothache relief, numbing, “stops tooth pain” — the clove gel data (Alqareer 2006) come from a dental anesthesia setting; drug-like claims about bad breath.
Helps clean the mouth, as an extra step alongside brushing
Instead of: claims to act on bacteria, percentage-of-germs figures, replacing brushing.
Contains clove bud oil (Eugenia Caryophyllus Flower Oil)
Instead of: “naturally preserved with clove”, “preservative-free”, “all-natural”.
Everyday oral care
Instead of: drug-like claims about tooth decay, gum inflammation, mouth ulcers, canker sores or periodontal disease.
Alcohol-free (when the formula contains no ethanol)
Describes the composition; stated only after confirming that flavors and other ingredients carry no ethanol.
Directions and warnings
Rinse and spit, do not swallow. Keep out of reach of children — children aged 3 months and 15 months have suffered fulminant liver failure after swallowing clove oil (under 8 mL and 10 mL; Eisen 2004; Janes 2005); the finished product contains a very low level, but swallowing concentrated oil needs emergency care at once. Positioned for adults: our clove oil article recommends not putting clove into products for young children; extending to children over 6 who can rinse and spit (the cut-off on the alcohol-free mouthwash page) needs a separate safety assessment. People already allergic to fragrance or eugenol should not use it; stop if burning or irritation occurs. Pregnancy and breastfeeding: not enough data, ask a doctor. Tooth pain or persistent bad breath needs a dentist. Instead of: safe to swallow, suitable for babies, hypoallergenic.
Manufacturing specifications
Current capabilities
- Texture
- Clear solution, colorless or with a color permitted for oral care products.
- Pack formats
- PET bottles with dosing caps, travel bottles, single-use sachets. Volume agreed when packaging is selected.
- Minimum order quantity
- Agreed per order and per flavor.
- Testing
- Tested at a GLP / ISO 17025-accredited laboratory; a certificate of analysis is supplied with every lot.
- Dossier
- Product Information File (PIF) and notification dossier prepared by Butter-C, with an essential oil COA stating the plant part and a methyleugenol calculation sheet.
- Packaging
- Label design, printing and packing run in parallel with formula work.
Suggested product concept
Alcohol-free clove and mild mint mouthwash with zinc
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.
Clove bud oil
The named scent, warm taste; level calculated from the lot's methyleugenol COA and set on tasting samples.
Zinc gluconate
The ingredient behind the fresh-breath positioning, total zinc within Annex III Ref 24.
Alcohol-free, mild mint
Low-dose menthol balances the heat; polyols mask zinc astringency; clear solution.
250 ml bottle
Light-protective bottle, dosing cap; label: rinse and spit, do not swallow, keep out of reach of children.
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.
Breath ingredient
Zinc gluconate or CPC — decides the aftertaste and the testing approach.
Clove intensity
Gently warm or clearly spicy, within the methyleugenol cap of the oil lot.
Companion flavors
Mild mint, strong mint, light cinnamon, menthol-free — each added flavor needs a methyleugenol and allergen declaration.
Sweetness
Sorbitol, xylitol, with or without sucralose; set on tasting samples.
Target market
Domestic or EU export (name “Eugenol” and “Eugenia Caryophyllus Oil” above the EU thresholds).
Product set
Paired with a clove-flavored herbal toothpaste in an oral care set; total methyleugenol calculated separately for each product.
Further reading
Related topics
Clove essential oil (Eugenia caryophyllus) in cosmetics
Eugenol, dental and in vitro data, allergy, and how to calculate the level under the ASEAN methyleugenol limit (in Vietnamese).
Eugenol in cosmetics
IFRA limits by product type, fragrance allergens and EU labeling (in Vietnamese).
Alcohol-free mouthwash manufacturing
The general technical base of the alcohol-free line; this page focuses on clove.
Oral care essential oil manufacturing
Essential oils diluted in a carrier oil, as drops or oil pulling.
Xylitol mouthwash manufacturing
Another alcohol-free line in the group, with xylitol as the named ingredient.
Oral care routine
Mouthwash is an extra step, used at a different time from 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 (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).
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