Label: AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0180-3, 58443-0180-5 - Packager: Prime Enterprises, Inc.
- 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 January 17, 2020
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- Active ingredients
- Purpose
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- Inactive Ingrediets:
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- PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0180 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 CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) CITRIC ACID ACETATE (UNII: DSO12WL7AU) COCO MONOETHANOLAMIDE (UNII: C80684146D) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCOL STEARATE (UNII: 0324G66D0E) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0180-5 266 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2015 2 NDC:58443-0180-3 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 06/01/2015 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0180) , pack(58443-0180) , manufacture(58443-0180) , analysis(58443-0180)