BUTTER-C
Signature ingredients
Climbazole shampoo OEM/ODM manufacturing
Climbazole Anti-Dandruff Shampoo · OEM/ODM
Climbazole (INCI: Climbazole) is a synthetic azole compound, an imidazole derivative, used in rinse-off shampoos and conditioners to remove dandruff and help reduce visible flakes, and also used as a preservative. Because of these two roles, the ASEAN Cosmetic Directive has two separate entries: Annex III for the anti-dandruff purpose (shampoo up to 2.0%, conditioner 0.5%, with the purpose apparent from the presentation of the product) and Annex VI for the preservative role. The evidence is limited to moderate: climbazole is highly active against Malassezia yeasts in the test tube, but in people the data come mainly from shampoos that combine climbazole with other actives, mostly run by companies — and one large trial found that adding climbazole did not necessarily beat an optimized base. Unlike a zinc pyrithione shampoo with suspended particles, climbazole is fully dissolved in the base, so the real work is dissolving it properly, assaying every batch and optimizing the base so the active stays on the scalp. Climbazole is in Butter-C's ingredient list, and we offer full-service OEM/ODM manufacturing, from formulation and active assay to a labeled product and its notification dossier.
Formula base
Dissolved climbazole, the cleansing base and cationic polymers
Climbazole makes up from a few parts per thousand to under 2% of the formula; the surfactant and polymer base decides whether the active fully dissolves, stays stable and remains on the scalp after rinsing.
Climbazole: raw material and COA
CAS 38083-17-9, C₁₅H₁₇ClN₂O₂, 292.76 g/mol; IUPAC name 1-(4-chlorophenoxy)-1-imidazol-1-yl-3,3-dimethylbutan-2-one (PubChem CID 37907). Computed XLogP3 of 3.7 — an oil-loving substance with low water solubility. Climbazole is in Butter-C's existing ingredient list; the COA states INCI, CAS and purity for every lot.
Fully dissolved
Per Butter-C's climbazole article: dissolve completely according to the supplier's technical data sheet (TDS) — usually pre-dissolved in the surfactant phase or a glycol (formulation experience) before combining the batch; check that no crystals remain and that it does not recrystallize in the cold. Because it dissolves fully, a climbazole shampoo can be clear or pearlescent and needs no particle-suspending system as zinc pyrithione does.
Cleansing base
Sodium Laureth Sulfate with Cocamidopropyl Betaine is the familiar base; levels are calculated as active matter because the raw materials are solutions. The base is not only for cleansing: the source article notes that the base should be optimized so the active stays on the scalp (Schwartz et al., 2013).
Cationic polymers and conditioning agents
Guar Hydroxypropyltrimonium Chloride and Polyquaternium-10 keep hair soft and less tangled with frequent washing; Panthenol helps the hair fiber hold moisture. Cationic polymers can make the shampoo slightly hazy (formulation experience) — test clarity if a clear product is wanted.
Key technical points
Two ASEAN entries, trial levels, the role of the base and safety
These five points are where a climbazole shampoo differs from a generic anti-dandruff shampoo.
Two ASEAN entries: active and preservative
ASEAN Annex III (release 2026-1), Ref 326 "Climbazole": "a) Rinse-off Anti-Dandruff Shampoo" 2.0%; "b) Rinse-off Anti-Dandruff Conditioners" 0.5%; condition for (a) and (b): "for purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product." Annex VI Ref 32 (preservative): "Hair lotions" 0.2%, "Face creams" 0.2%, "Rinse-off shampoo" 0.5%, "Rinse-off hair conditioner" 0.5%; footnote (15): "For use other than as a preservative, see Annex III, Part 1, entry 326". Climbazole is not named in Annexes II or VII.
Trial levels are not regulatory levels
Shampoos in human trials used 0.45% climbazole combined with 0.5% piroctone olamine (Schmidt-Rose et al., 2011) and 0.65% climbazole (Wigger-Alberti et al., 2001). 2.0% is a maximum, not a recommended level; actual market levels have no verified public source. Butter-C sets the level according to the base and test results on the finished product.
The base matters more than the number of actives
In a randomized, double-blind trial in 620 people over 4 weeks, a zinc pyrithione shampoo with an optimized base gave better results than a shampoo combining zinc pyrithione with climbazole at all 4 weekly assessments (Schwartz et al., 2013 — company authors; levels not stated). Butter-C optimizes the surfactant base, cationic polymers and active assay rather than stacking more actives.
An active still needs a challenge-tested preservative system
When climbazole acts as the anti-dandruff active, the formula still goes through a preservative challenge test to ISO 11930 (source article). Within the same line, leave-on scalp products (serums, sprays) are not covered by Ref 326, so under Butter-C's reading (to be confirmed by regulatory staff) they can contain climbazole only as a preservative within Ref 32, with no anti-dandruff claim.
Safety and information from the EU
The SCCS (SCCS/1600/18, 2018) concluded that climbazole is safe as an anti-dandruff active up to 2% in shampoo, including when used together with a hair lotion, face cream and foot care product containing 0.2% climbazole as a preservative; a table in the same document gives a margin of safety of 89 for this four-product combination (the document does not explain the discrepancy). Use at 0.5% as a preservative in whole-body leave-on products was not considered safe. On excised human skin, dermal absorption was significant; according to the abstract by Champmartin et al. (2025), the EU classifies climbazole as an acute toxicant (Category 4) and ECHA has confirmed an endocrine disruptor concern. Current EU limits are confirmed by regulatory staff before export.
Three formulation directions
Three climbazole shampoo lines
Climbazole alone, optimized base
Climbazole dissolved in a sulfate – betaine base with a cationic polymer, neutral feel, for daily washing. A note on evidence: in the abstracts searched, no controlled trial of a shampoo containing only climbazole was found; the human data on a shampoo whose abstract names climbazole alone (0.65%) come from one small study that reports no control group — so claims rest on testing of the finished product itself.
Climbazole – piroctone olamine, mint cooling
Following the formula of Schmidt-Rose et al. (2011): 0.45% climbazole with 0.5% piroctone olamine; in a half-head home-use comparison in people with moderate to severe dandruff, this shampoo reduced dandruff as much as a commercial 1% zinc pyrithione shampoo (company authors; sample size not given in the abstract). Piroctone olamine under Annex VI Ref 35 (rinse-off products 1%); Menthol adds a cooling feel, with the level set by sensory and eye irritation testing.
Climbazole – salicylic acid to loosen flakes
Salicylic Acid helps loosen flakes: Annex III Ref 98, rinse-off hair products up to 3.0%, including any use as a preservative, not for children under three. Each substance is checked against its own limit; clarity, pH and stability of both actives are tested in the actual base.
Anti-dandruff shampoo – conditioner set
A rinse-off anti-dandruff conditioner under Ref 326 (b) up to 0.5% climbazole; opaque pump or flip-cap bottles, trial sachets. The active is assayed in the trial sachets too (plant practice).
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.
- Climbazole content
- Assayed in the finished product for every batch, at baseline and after accelerated aging; not above 2.0% (shampoo) or 0.5% (conditioner).
- Combined actives
- Piroctone olamine or salicylic acid assayed when present, each checked against its own limit.
- Dissolution and clarity
- No crystals after mixing; observed at cold, room and elevated temperature to detect recrystallization or haze.
- pH and viscosity
- Measured at 25°C when fresh and after aging.
- Color and odor
- Monitored after storage at 40°C and under light.
- Microbiology and preservative challenge
- Tested at a GLP/ISO 17025 laboratory; the formula passes a preservative challenge test to ISO 11930 even though climbazole has an Annex VI entry.
- Efficacy assessment (if figures are claimed)
- Dandruff flake assessment in people with dandruff, at an independent testing unit, with the formula itself; changing the surfactant base or polymer after testing means re-testing.
- Eye irritation
- The finished product is assessed with a method proposed by the testing laboratory (especially the menthol line); the label says to avoid contact with the eyes.
Claims
Claims within cosmetic scope
In Vietnam and ASEAN, a climbazole shampoo is a cosmetic when its claims stop at removing dandruff and caring for the scalp, and the anti-dandruff purpose must be apparent from the product (the condition of Annex III Ref 326). The evidence is limited to moderate: high activity against 22 Malassezia furfur strains in the test tube (Schmidt & Rühl-Hörster, 1996 — company authors; low inhibitory concentrations in the test tube are not enough to conclude on a shampoo's performance); in people, the data are mainly on combination shampoos. The study of a 0.65% climbazole shampoo in 30 people with moderate to severe seborrheic dermatitis of the scalp (Wigger-Alberti et al., 2001) was a medical setting at a university dermatology clinic, and its abstract reports no control group — it is not used for claims. Butter-C reviews label and promotional wording when preparing the notification dossier.
Removes dandruff, helps reduce visible flakes
Instead of: drug-like claims about dandruff, "eliminates dandruff permanently".
Helps relieve dandruff-related itchiness (when backed by human test data on the finished product)
Instead of: drug-like promises to end scalp itching.
Leaves the scalp clean and comfortable
Instead of: claims to act on Malassezia, claims about seborrheic dermatitis, scalp psoriasis or eczema, comparisons with ketoconazole or other drug substances.
Soft, not dry hair with frequent washing
Instead of: restores damaged hair.
Results after a number of washes
Only stated after testing the formula itself on people. Instead of: quoting study figures from other products.
No hair loss claims
Appendix 03-MP does not accept claims about hair loss or hair growth. Instead of: prevents hair loss, stimulates hair growth.
Directions and cautions
Massage evenly into the scalp and rinse well, use regularly as labeled; avoid contact with the eyes, and rinse well with water if it gets in. People with a history of cosmetic allergy try it first on a small area; pause if the scalp is scratched or stinging. A red scalp, thick adherent scales, spreading to the forehead or behind the ears, oozing or patchy hair loss needs a dermatologist's assessment. Pregnancy or breastfeeding: not enough data, ask a doctor. Instead of: "non-irritating", "safe for pregnant women".
Manufacturing specifications
Available capabilities
- Texture
- Clear or pearlescent shampoo, with or without a cooling feel; rinse-off cream conditioner.
- Actives
- Climbazole, piroctone olamine and salicylic acid are in Butter-C's existing ingredient list, with COA.
- Pack formats
- Pump bottles, flip-cap bottles, trial sachets. Volume agreed when packaging is selected.
- Minimum order quantity
- Agreed per order.
- Testing
- Performed at a GLP/ISO 17025 laboratory, including climbazole assay; results delivered with every batch.
- Documentation
- Product information file (PIF) and notification dossier prepared by Butter-C, with the active's COA.
- Packaging
- Label design, printing and packing run in parallel with formula development.
Suggested product concept
Climbazole – piroctone olamine anti-dandruff shampoo with a mint cooling feel
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.
Two dissolved actives
0.45% climbazole with 0.5% piroctone olamine, as in the formula tested in people; fully dissolved in the surfactant phase, both assayed in every batch.
A base that helps the actives stay
Sodium Laureth Sulfate, Cocamidopropyl Betaine and Guar Hydroxypropyltrimonium Chloride; changing the base after efficacy testing means re-testing.
Light cooling, hair not dry
Menthol at a moderate level; Panthenol and Polyquaternium-10 keep hair soft with washing several times a week.
400 ml bottle, directions for regular use
Opaque pump bottle; the label makes the anti-dandruff purpose clear, says to massage into the scalp and rinse well, and to avoid contact with the eyes.
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.
Target market
Vietnam and ASEAN under Annex III Ref 326 and Annex VI Ref 32; for EU export, regulatory staff confirm the current limits before the formula is fixed.
Climbazole level
Shampoo up to 2.0%, conditioner 0.5%; set by the base and test results, the maximum is not a recommended level.
Combined actives
Piroctone olamine (Annex VI Ref 35), salicylic acid (Annex III Ref 98: rinse-off hair products up to 3.0%, not for children under three) or zinc pyrithione (Annex III Ref 101: rinse-off hair products 1.0%; banned in the EU) — each within its own limit; a second active does not necessarily beat an optimized base.
Feel and user group
Mint cooling or neutral; men, women, oily scalp, long hair.
Other products in the line
Rinse-off anti-dandruff conditioner (up to 0.5%). Leave-on scalp serums and sprays are not positioned as anti-dandruff with climbazole; there it is only a preservative (hair lotions 0.2%, Ref 32). Body lotions do not use climbazole as a preservative (SCCS: 0.5% in whole-body leave-on products is not safe).
Further reading
Related knowledge
Climbazole in cosmetics
Human and in vitro evidence, the SCCS assessment, Annex III Ref 326 and Annex VI Ref 32 (in Vietnamese).
Anti-dandruff shampoo manufacturing
The general page on anti-dandruff actives; this page focuses on climbazole.
Piroctone olamine shampoo manufacturing
An active often combined with climbazole, also fully dissolved.
Zinc pyrithione (ZPT) shampoo manufacturing
A suspended-particle active; the 620-person trial on an optimized base.
Dandruff and oily scalp
Why the scalp flakes, what a shampoo can do and when to see a dermatologist (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).
Head office: Huu Le village, Dai Thanh commune, Hanoi · Factory: Thanh Oai Industrial Cluster, Binh Minh commune, Hanoi, Vietnam
Hotline +84 967 176 511 · [email protected] · Privacy policy ← Full catalog