Label: GOLD COSMETICS BLEACH CREAM- hydroquinone cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1902-1 - 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 September 5, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
Warnings:
Sun exposure should be limit by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Proper use of skin bleaching creams is extremely important, and directions should be followed carefully at all times.
Large skin areas, such as the entire face, should not be bleached at once due to the possibility of skin discoloration.
Product should be used on the darkened area of skin only.
For external use only.
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOLD COSMETICS BLEACH CREAM
hydroquinone cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1902 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 mL Inactive Ingredients Ingredient Name Strength 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) GLYCERIN (UNII: PDC6A3C0OX) 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:69435-1902-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 09/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 09/05/2019 Labeler - Peer Pharm Ltd (514678390) Registrant - Peer Pharm Ltd (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd 514678390 manufacture(69435-1902) , label(69435-1902)
