Label: EXENCE WHITE- hydroquinone lotion

  • 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

    The latest and amazing formulation has been implemented for EXENCE WHITE BODY MILK NATURAL Clear Tone to brighten complexion color and gradually reduce freckles and dark spot of
    the skin caused by age, sun, pregnancy.
    This Milk can be classified Top Rank efficacy for brightening action (Hydroquinone 2%) assuring complexion uniformity and luminosity; it provides antioxidant action (Rosmarinus Officinalis
    Extract ) helping to preserve the skin texture by promoting collagen and elastin synthesis. The Ursolic Acid and Rosmarinic Acid provide antimicrobial, anti irritant, anti inflammatory and
    refreshing actions.

  • Use

    USE: spread a thin layer of milk on the skin area to be brightened 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, Stearic Acid, Propylene Glycol, Palmitic Acid, Fragrance, *, Sodium Sulfite, Potassium Cetyl Phosphate, Isopropyl Myristate, Cetyl Alcohol, Glyceryl Stearate, 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 milk on the skin area to be brightened and massage delicately. Continue the application for at least 4 weeks.

  • INGREDIENTS AND APPEARANCE
    EXENCE WHITE 
    hydroquinone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66273-0002
    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)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    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:66273-0002-212 in 1 BOX
    1NDC:66273-0002-1500 mL in 1 BOTTLE, PLASTIC
    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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