Label: EXENCE WHITE- hydroquinone 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 July 12, 2011

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  • Natural Clear Tone - Lightening

    EXENCE WHITE CREAM NATURAL Clear Tone is a rich textured cream to brighten complexion color and gradually reduce freckles and dark spot of the skin caused by age, sun, pregnancy.
    Excellent antioxidant cream promoting collagen and elastin synthesis with antimicrobial, anti irritant, anti inflammatory and refreshing actions.

  • Use

    Use: spread a thin layer of cream on the skin area to be brightened twice a day and massage delicately. Continue the application for at least 4 weeks.

  • Caution

    Caution: For external use only - It contains Hydroquinone 2% - Keep away from eyes - Apply on small surfaces only - In case of allergic symptoms, immediately suspend the application - Do not use on children under 12.

  • Active Ingredients

    ACTIVE INGREDIENTS: Hydroquinone 2.00%

  • Ingredients

    Ingredients: Water, Propylene Glycol, Mineral Oil, Stearic Acid, Palmitic Acid,Glyceryl Stearate, Cetyl Alcohol, Fragrance, *, Sodium Sulfite, Potassium Cetyl Phosphate, Isopropyl Myristate, Citric Acid, Lactic Acid, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Propylparaben, Brassica Campestris (Rapeseed) Seed Oil, Rosmarinus Officinalis (Rosemary ) Leaf Extract, Hydroxyisohexyl 3-cyclohexene Carboxaldehyde, Hexyl Cinnamal.

  • STORAGE AND HANDLING

    STORE IN COOL, DRY PLACE - DO NOT EXPOSE TO DIRECT SUNLIGHT - ALWAYS CLOSE AFTER USE.

  • Drug Facts

    label

  • Caution

    Caution: For external use only - It contains Hydroquinone 2% - Keep away from eyes - Apply on small surfaces only - In case of allergic symptoms, immediately suspend the application - Do not use on children under 12.

  • Use

    Use: spread a thin layer of cream on the skin area to be brightened twice a day and massage delicately. Continue the application for at least 4 weeks.

  • INGREDIENTS AND APPEARANCE
    EXENCE WHITE 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66273-0001
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE4 mL  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66273-0001-212 in 1 BOX
    1NDC:66273-0001-1200 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A07/12/2011
    Labeler - AQUIMPEX SPA (440651672)
    Establishment
    NameAddressID/FEIBusiness Operations
    AQUIMPEX SPA440651672manufacture
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