Label: CLEAR ACTION- 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 19, 2011

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  • PURPOSE

    Dermofading Cream Face CLEAR MAXI TONE 5+ specially designed to impart youthful glow and supreme brightness to dull skin with uneven tone. Its action enhances skin luminosity in
    as little as few weeks.

  • Use

    Use: spread a thin layer on skin areas to be treated; apply mornings and evenings on perfectly cleansed skin, massaging delicately until complete absorption.

  • Caution

    Caution: For external use only - It contains Hydroquinone - 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, Propylparaben, Methylparaben, Brassica Campestris (Rapeseed) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract. 02/10

  • STORAGE AND HANDLING

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

  • Use

    Use: spread a thin layer on skin areas to be treated; apply mornings and evenings on perfectly cleansed skin, massaging delicately until complete absorption.

  • Caution

    Caution: For external use only - It contains Hydroquinone - 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.

  • Drug Facts

    label

  • INGREDIENTS AND APPEARANCE
    CLEAR ACTION 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66273-0003
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE10 mL  in 500 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)  
    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:66273-0003-312 in 1 BOX
    1NDC:66273-0003-21 in 1 CELLO PACK
    1NDC:66273-0003-1500 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A07/19/2011
    Labeler - AQUIMPEX SPA (440651672)
    Establishment
    NameAddressID/FEIBusiness Operations
    AQUIMPEX SPA440651672manufacture
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