Label: EB5 AGE SPOT TREATMENT- hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL

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 December 27, 2018

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  • Drug Facts

  • Active ingredient

    Hydroquinone 2%

    Purpose

    Skin lightener

  • Uses

    Lightens dark spots in the skin such as freckles, age spots an liver spots.

  • Warnings

    • For external use only.
    • Avoid contact with eyes or eyelids.
    • Some users of this product may experience milld skin irritation. Consult physician if skin irritation becomes severe.

    Do not use 

    • on children under 12, unless directed by physician

    Keep out of reach of children.

    If swallowed, contact physician or poison control center immediately.

  • SPL UNCLASSIFIED SECTION

    Store at room temperature.

  • Directions

    • Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.
    • Lightening effect of this product may not be noticeable when used on very dark skin.
    • Children under 12 years of age: do not use unless directed by a doctor.
    • Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from recurring.
  • Other Ingredients:

    Acer Saccharum (Sugar Maple) Extract, Aminomethyl Propanol, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Caprylic/Capric/Myristic/Stearic Triglyceride, Carbomer, Cetearyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Octisalate, Oleth-5 Phosphate, Phenoxyethanol, Saccharum Officinarum (Sugar Cane) Extract, Sodium Metabisulfite, Steareth-21, Stearyl Alcohol, Vaccinium Myrtillus (Bilberry) Extract.

  • Question of Comments?

    1-800-683-2325, M-F, 8am-5pm PST.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    EB5 AGE SPOT TREATMENT 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON (UNII: 24RS0A988O)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTISALATE (UNII: 4X49Y0596W)  
    OLETH-5 PHOSPHATE (UNII: 44FE98F6UX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BILBERRY (UNII: 9P2U39H18W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71221-995-061 in 1 BOX12/15/2018
    1177.4 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A12/15/2018
    Labeler - Elements Brands, Inc. (006166707)