Label: AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT- pyrithione zinc lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0184-3 - 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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- Official Label (Printer Friendly)
- Active ingredient:
- Purpose
- Indications:
- Warning:
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Directions:
- Shake well.
- Use after shampooing and towel drying hair. Part hair section by section. Apply directly onto the scalp and spread using fingertips. Gently massage into scalp. Leave in.
- Apply to affected areas one to four times daily or as directed by a doctor
- Children under 6 months of age: ask a doctor.
- Inactive Ingrediets:
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT
pyrithione zinc lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0184 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 2.14 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CETRIMONIUM BROMIDE (UNII: L64N7M9BWR) CHLORPHENESIN (UNII: I670DAL4SZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) PALM OIL (UNII: 5QUO05548Z) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) 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:58443-0184-3 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 08/01/2015 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0184) , pack(58443-0184) , manufacture(58443-0184) , analysis(58443-0184)