Label: GOLD COSMETICS ADI CLEAR- hydroquinone cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1704-1 - Packager: Peer Pharm Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 16, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOLD COSMETICS ADI CLEAR
hydroquinone cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1704 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 5 mg in 100 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) DECYL OLEATE (UNII: ZGR06DO97T) SODIUM DITHIONATE (UNII: RPF7Z41GAW) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETEARETH-30 (UNII: 1R9DCZ5FOX) STEARETH-21 (UNII: 53J3F32P58) STEARETH-2 (UNII: V56DFE46J5) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CHLORPHENESIN (UNII: I670DAL4SZ) CETYL ALCOHOL (UNII: 936JST6JCN) ALLANTOIN (UNII: 344S277G0Z) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1704-1 30 mg in 1 TUBE; Type 0: Not a Combination Product 06/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 06/05/2017 Labeler - Peer Pharm Ltd (514678390) Registrant - Peer Pharm Ltd (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd 514678390 manufacture(69435-1704) , label(69435-1704)