aed49bfe-e016-46ac-a025-81b47cc08147

SPL v5
SPL
SPL Set ID aed49bfe-e016-46ac-a025-81b47cc08147
Route
topical
Published
Effective Date 2022-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pyrithione zinc (1 g)
Inactive Ingredients
water cetostearyl alcohol behentrimonium chloride cetyl esters wax aloe vera leaf keratin, type i cytoskeletal 40 hydrolyzed sheep wool keratin (200 mw) amodimethicone (800 cst) peppermint oil polysilicone-15 menthol cetrimonium chloride alcohol edetate disodium anhydrous trideceth-12 caprylyl glycol methylisothiazolinone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-12-20
Purpose

Anti-dandruff

Description

Zinc Pyrithione 1%

Medication Information

Warnings

For external use only. 

When using this Product: Avoid contact with eyes, If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if  Condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff 

Purpose

Anti-dandruff

Directions

Apply to wet hair and scalp with gentle massage, leave in for 2 minutes, rinse 

For best results use atleast 2 times per week or as direacted by a doctor

For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff shampoo

Inactive Ingredients

WATER, CETEARYL ALCOHOL, BEHENTRIMONIUM CHLORIDE, CETYL ESTERS, ALOE VERA GEL, KERATIN, HYDROLYZED KERATIN, AMODIMETHICONE, PEPPERMINT OIL, POLYSILICONE-15, MENTHOL, CETRIMONIUM CHLORIDE, SD ALCOHOL 40-B, DISODIUM EDTA, TRIDECETH-12, CAPRYLYL GLYCOL, METHYLISOTHIAZOLINONE

Description

Zinc Pyrithione 1%

Section 50565-1

Product Label

Active Ingredient

Zinc Pyrithione 1%

Structured Label Content

Warnings

For external use only. 

When using this Product: Avoid contact with eyes, If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if  Condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff 

Purpose

Anti-dandruff

Directions

Apply to wet hair and scalp with gentle massage, leave in for 2 minutes, rinse 

For best results use atleast 2 times per week or as direacted by a doctor

For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff shampoo

Inactive Ingredients (Inactive ingredients)

WATER, CETEARYL ALCOHOL, BEHENTRIMONIUM CHLORIDE, CETYL ESTERS, ALOE VERA GEL, KERATIN, HYDROLYZED KERATIN, AMODIMETHICONE, PEPPERMINT OIL, POLYSILICONE-15, MENTHOL, CETRIMONIUM CHLORIDE, SD ALCOHOL 40-B, DISODIUM EDTA, TRIDECETH-12, CAPRYLYL GLYCOL, METHYLISOTHIAZOLINONE

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient (Active ingredient)

Zinc Pyrithione 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.497612 · Updated: 2026-03-14T23:13:34.159935