EB5 AGE SPOT TREATMENT (HYDROQUINONE) CREAM [ELEMENTS BRANDS, INC.]

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EB5 AGE SPOT TREATMENT (HYDROQUINONE) CREAM [ELEMENTS BRANDS, INC.]
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NDC 71221-995-06
Set ID b70164e1-433c-420a-b848-1cbefa9278b3
Category HUMAN OTC DRUG LABEL
Packager Elements Brands, Inc.
Generic Name
Product Class
Product Number
Application Number PART358A
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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)
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