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Piroctone olamine shampoo OEM/ODM manufacturing
Piroctone Olamine Anti-Dandruff Shampoo · OEM/ODM
Piroctone olamine (INCI: Piroctone Olamine) is the monoethanolamine salt of piroctone, a hydroxypyridone compound, used in shampoos to cleanse dandruff and reduce visible flakes. It is an ingredient with “two roles”: the ASEAN list places it in Annex VI (preservatives, Ref 35: 1% for rinse-off products) with a (+) mark, which allows use for another purpose apparent from the product's presentation, such as an anti-dandruff agent in shampoo. Human shampoo trials used 0.2–1% piroctone olamine, alone or with salicylic acid or climbazole, and consistently showed less dandruff; most were run by companies with small samples, so the evidence is moderate. Research also shows that efficacy depends not only on the figure on the label but on how much active the shampoo base leaves on the scalp, and on leaving the lather on for a few minutes before rinsing. Butter-C keeps a 1% ceiling for shampoo under a cautious reading, fully dissolves the active, controls metal ions to hold the color and assays piroctone olamine in every batch — offering turnkey OEM/ODM manufacturing, from formula development and testing to labeled finished goods and the notification dossier.
Formula base
Piroctone olamine, cleansing base and active-retaining polymers
Piroctone olamine is fully dissolved in the shampoo, unlike zinc pyrithione, which is an insoluble particle that must be suspended; the rest of the formula decides how much active stays on the scalp after rinsing.
Piroctone Olamine: material and certificate of analysis
A solid powder, CAS 68890-66-4 (piroctone: 50650-76-5), available in Butter-C's ingredient list. The certificate of analysis should state purity and secondary amine content, because under a strict reading Butter-C also applies the conditions for monoethanolamine salts (Annex III Ref 61: purity not below 99%, secondary amines at most 0.5% in the raw material, not to be used with nitrosating systems).
Cleansing base
Sodium laureth sulfate with cocamidopropyl betaine is the familiar base. The base directly affects efficacy: one trial in 30 men found 0.2% piroctone olamine in a base with an added amphiphilic surfactant blend equivalent to 0.5% in a simple base (Georgalas, 2004 — authors from an ingredient supplier, small sample).
Cationic polymers and conditioners
Guar hydroxypropyltrimonium chloride and polyquaternium-10 keep hair soft and also influence how much active deposits: lower micelle stability and higher cationic charge density increased piroctone olamine retained on the scalp and in the follicle infundibulum, together with better anti-dandruff efficacy (Johnson et al., 2023 — company authors).
Combined actives (optional)
Salicylic acid helps loosen flakes (Annex III Ref 98: rinse-off hair products up to 3.0%, not for children under three); climbazole (Annex III Ref 326: rinse-off anti-dandruff shampoo up to 2.0%); menthol for a cooling feel. Each substance is checked against its own limit.
Key technical points
Limits, dissolution, metal ions and lather time
These four points are where a piroctone olamine shampoo differs from a generic anti-dandruff shampoo.
A 1% ceiling: a cautious reading
ASEAN Annex VI Ref 35 sets 1% for “Rinse-off products” and 0.5% “For other products”. The annex preamble allows (+) substances to be used “in concentration other than those laid down in this ANNEX” for other purposes, e.g. “as anti-dandruff agents in shampoos”; Annexes II and III have no separate entry for piroctone, so the text gives no figure for anti-dandruff use. Butter-C does not exceed 1% in shampoo — a reading to be confirmed by regulatory staff. The shampoo trials that report a concentration all fall within 0.2–1%.
Full dissolution and stability
In-house practice: dissolve piroctone olamine in a warm portion of the surfactant until clear, or pre-dissolve it in propylene glycol (solubility about 249 mg/mL at 32 °C — Tang et al., 2023) before adding it to the base. In water and buffer at 32 °C its content fell significantly after 4 days (Tang, 2023), while dilute aqueous solution at about pH 7 was heat-stable (Coiffard, 1999) — different conditions, so the active is assayed at the start and after accelerated aging in the actual base.
Metal ions and color
Piroctone olamine interacts with iron (in vitro and animal data — Sigle, 2006; Nolen, 1989). Factory practice: disodium EDTA, treated water, stainless equipment, control of metal impurities in raw materials, and monitoring of color change after storage at 40°C and under light.
Leave the lather on for a few minutes
In a half-head trial in people with severe dandruff (two groups of 21), leaving a 1% piroctone olamine shampoo lather on for 5 minutes reduced flaking more than rinsing straight away (Pierard-Franchimont et al., 2003). Label directions should state this washing method.
Three formulation directions
Three piroctone olamine shampoo lines
Single-active piroctone olamine for daily use
0.5% as in a trial in 100 people with dandruff over 3 weeks (Hu et al., 2024 — company authors); sulfate–betaine base, cationic polymer, neutral feel; suited to women and long hair.
Piroctone olamine and salicylic acid
Following the design of Loden and Wessman (2000): 0.75% piroctone olamine with 2% salicylic acid; salicylic acid helps loosen flakes, needs pH adjustment and a not-for-children-under-three statement.
Cooling piroctone olamine and climbazole
0.5% piroctone olamine with 0.45% climbazole as in the formula of Schmidt-Rose et al. (2011), plus menthol; suited to men and oily scalps. Each active is checked against its own limit.
Packaging is chosen together with the formula
Opaque or dark bottles, pump or flip cap, trial sachets. Opaque bottles hide slight color shifts, but color is still monitored in stability testing.
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 to production. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- Piroctone olamine content
- HPLC assay on the finished product for each batch, at the start and after accelerated aging; not above 1%.
- Raw material certificate of analysis
- Purity, secondary amines, nitrosamines (Annex III Ref 61 conditions, strict reading).
- pH and viscosity
- Measured at 25°C; they affect active stability and how washing feels.
- Clarity and color
- No haze or crystallization in the cold; color change monitored after storage at 40°C and under light.
- Conditioning performance
- Assessed on hair tresses: slip when rinsing, ease of combing.
- Microbiology and preservative challenge
- Tested at a GLP / ISO 17025-accredited laboratory; although piroctone olamine has an Annex VI entry, the formula still undergoes a preservative efficacy test to ISO 11930.
- Efficacy assessment (if figures are claimed)
- Adherent scalp flaking score or quadrant-based area–severity score in people with dandruff at an independent testing unit; changing the surfactant base or polymer after testing means retesting.
- Eye irritation
- In rabbits, 0.5% piroctone olamine was mildly irritating to the eye (SCCNFP, 2002); the finished product is assessed by methods proposed by the testing laboratory.
- Packaging compatibility
- Watch for staining, pump force and leakage; nitrite-free packaging (Annex III Ref 61).
Claims
Claims within cosmetic scope
A piroctone olamine shampoo is a cosmetic; its benefits stop at cleansing dandruff and caring for the scalp. The evidence is moderate: several small human trials with consistent results, mostly run by companies, many using combination formulas; there are no data ranking piroctone olamine alone against zinc pyrithione or climbazole. Butter-C reviews label and marketing wording when preparing the notification dossier.
Cleanses dandruff, helps reduce visible flakes
Instead of: drug-like dandruff claims, “permanently removes dandruff”.
Helps relieve the itchy feeling from dandruff (with self-assessment data on the finished product)
Instead of: promises to end scalp itching like a medicine.
Leaves the scalp clean and comfortable
Instead of: claims of action on Malassezia or other fungi, claims about seborrheic dermatitis or scalp psoriasis.
Soft hair, not dry, with frequent washing
Instead of: claims of restoring damaged hair.
Results after a number of washes, comparisons with other actives
Only with a human assessment of the actual formula. Instead of: “more effective than zinc pyrithione” based on someone else's combination-formula trial.
No hair-loss claims
Some studies of shampoos containing piroctone olamine measured hair shedding or hair count — in a medical setting or company-funded, and not used for claims. Instead of: prevents hair loss, stimulates hair growth (not accepted under Appendix 03-MP).
Manufacturing specifications
Current capabilities
- Format
- Clear or pearlescent opaque shampoo, with or without a cooling feel.
- Active
- Piroctone olamine is in Butter-C's current ingredient list; climbazole and salicylic acid combined on request.
- Pack formats
- Pump bottles, flip-cap bottles, trial sachets. Volume is agreed when packaging is selected.
- Minimum order quantity
- Agreed per order.
- Testing
- Tested at a GLP / ISO 17025-accredited laboratory, including piroctone olamine assay; a certificate of analysis is delivered with each batch.
- Documentation
- Product Information File (PIF) and cosmetic product notification prepared by Butter-C, with the active's certificate of analysis.
- Packaging
- Label design, printing and packing run in parallel with formulation.
Suggested product concept
Cooling piroctone olamine–climbazole anti-dandruff shampoo
A product concept to help you picture the possibilities, not a ready-made product for sale. The actual formula is developed around your brand's positioning and price range.
Two anti-dandruff actives
0.5% piroctone olamine with 0.45% climbazole, fully dissolved in the surfactant phase; both assayed in every batch.
Active-retaining base
Sodium laureth sulfate, cocamidopropyl betaine and guar hydroxypropyltrimonium chloride; changing the base after efficacy testing means retesting.
Peppermint cooling, hair not left dry
Menthol at a moderate level; panthenol and dimethiconol keep hair soft with washing several times a week.
400 ml bottle with lather directions
Opaque pump bottle; the label says to massage into the scalp, leave the lather for a few minutes, rinse well and avoid contact with eyes.
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 develop a matching formula.
Active
Piroctone olamine alone, or combined with salicylic acid or climbazole.
Sales market
Domestic or export; products for the EU do not use zinc pyrithione (banned in the EU since 1 March 2022) — piroctone olamine is one option, with the EU limit confirmed by regulatory staff on the current text.
Target users
Men, women, long hair, oily scalps.
Feel
Peppermint cooling or neutral.
Cleansing base
With or without sulfates — a change of base means reassessing efficacy.
Product set
Anti-dandruff shampoo and conditioner in one line (climbazole in an anti-dandruff conditioner up to 0.5%).
Further reading
Related topics
Piroctone olamine in cosmetics
Scalp mechanism, table of shampoo trials, safety and how to read Annex VI (in Vietnamese).
Anti-dandruff shampoo manufacturing
The general page on anti-dandruff actives; this page focuses on piroctone olamine.
Dandruff and oily scalp
Why the scalp flakes, what shampoo can do and when to see a dermatologist (in Vietnamese).
Climbazole in cosmetics
An active often combined with piroctone olamine, and its two limit entries (in Vietnamese).
Tea tree oil shampoo manufacturing
When a brand wants a herbal story alongside an anti-dandruff active.
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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