Label: GOLD COSMETICS BLEACH CREAM- hydroquinone cream cream

  • 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

    Hydroquinone 5%

  • PURPOSE

    Face cream for gradual fading of dark spots

  • INDICATIONS & USAGE

    Face cream for gradual fading of dark spots

    Apply a very thin layer once a day, only at night, all over the face

  • DOSAGE & ADMINISTRATION

    Apply a very thin layer once a day, only at night, all over the face​

  • WARNINGS

    Warnings:

    • For external use only
    • Avoid contact with eyes
    • If contact occurs, rinse eyes thoroughly with water
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    Gold Cosmetics Bleach Cream

  • INGREDIENTS AND APPEARANCE
    GOLD COSMETICS BLEACH CREAM 
    hydroquinone cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1705
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    SODIUM DITHIONATE (UNII: RPF7Z41GAW)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1705-130 mg in 1 TUBE; Type 0: Not a Combination Product06/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A06/05/2017
    Labeler - Peer Pharm Ltd (514678390)
    Registrant - Peer Pharm Ltd (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd514678390manufacture(69435-1705) , label(69435-1705)
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