Label: AUSTRALIAN GOLD METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF- pyrithione zinc 1% shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0242-5 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 17, 2020
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- Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF
pyrithione zinc 1% shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10.32 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCOL STEARATE (UNII: 0324G66D0E) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) COCO MONOETHANOLAMIDE (UNII: C80684146D) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0242-5 266 mL in 1 TUBE; Type 0: Not a Combination Product 10/07/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/07/2016 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 manufacture(58443-0242) , label(58443-0242) , analysis(58443-0242) , pack(58443-0242)