Label: CONTROL ANTI-DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 46324-2421-1, 46324-2421-2, 46324-2421-3, 46324-2421-8
- Packager: AG Hair Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 15, 2023
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- ACTIVE INGREDIENT:
- USES:
- WARNING:
- STOP USE AND ASK A DOCTOR IF:
- KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
- DIRECTIONS:
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INACTIVE INGREDIENTS
WATER (AQUA, EAU), AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-4 RAPESEEDAMIDE, ALOE BARBADENSIS EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM HYDROXIDE, PANTHENOL, HYDROLYZED KERATIN, SODIUM PCA, TOCOPHERYL ACETATE, SODIUM HYDROXYMETHYLGLYCINATE, CITRIC ACID, FRAGRANCE (PARFUM), ENTHOL, TETRASODIUM GLUTAMATE DIACETATE, PROPANEDIOL.
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INGREDIENTS AND APPEARANCE
CONTROL ANTI-DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46324-2421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PEG-4 RAPESEEDAMIDE (UNII: 89575CN928) ALOE (UNII: V5VD430YW9) SODIUM HYDROXIDE (UNII: 55X04QC32I) PANTHENOL (UNII: WV9CM0O67Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MENTHOL (UNII: L7T10EIP3A) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46324-2421-8 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2011 06/30/2016 2 NDC:46324-2421-1 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2011 11/30/2015 3 NDC:46324-2421-2 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2011 10/14/2024 4 NDC:46324-2421-3 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2011 10/28/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/28/2011 10/31/2024 Labeler - AG Hair Ltd. (203691886)