TEATRICAL SKIN LIGHTENING SKIN LIGHTENER (HYDROQUINONE) CREAM [GENOMMA LAB USA INC.]

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  • TEATRICAL SKIN LIGHTENING SKIN LIGHTENER (HYDROQUINONE) CREAM [GENOMMA LAB USA INC.]

TEATRICAL SKIN LIGHTENING SKIN LIGHTENER (HYDROQUINONE) CREAM [GENOMMA LAB USA INC.]
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NDC 50066-055-01
Set ID bf642c92-e75a-4f66-a501-2997232ba86f
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA Inc.
Generic Name
Product Class
Product Number
Application Number PART358A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydroquinone 2%

  • Purpose

    Skin Lightener

  • Use

    Lightens dark (brownish) spots, blotches, freckles and discoloration of the skin.

  • Warnings

    For external use only

    Do not use on children under 12 years of age unless directed by a doctor.

    When using this product

    ♦
    you may experience mild skin irritation
    ♦
    avoid contact with eyes.

    Stop use and ask a doctor if skin irritation becomes severe.

    If pregnant or breast-feeding, ask a doctor before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.
    ♦
    Exposure to the sun should be limited by using a sunscreen agent, sun blocking agent or protective clothing to cover bleached skin when using and after treatment is completed in order to prevent darkening from reoccurring.
  • Other information

    ♦
    Store tightly closed.
    ♦
    Store at room temperature.
  • Inactive ingredients

    water, mineral oil, glyceryl stearate, cetyl alcohol, isopropyl myristate, PEG-100 stearate, propylene glycol, cetearyl alcohol, polysorbate 60, sodium metabisulfite, stearic acid, tocopheryl acetate, beta-carotene, diazolidinyl urea, iodopropynyl butylcarbamate, fragrance

  • Questions or comments?

    Call toll free 1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA Inc., Houston,
    TX 77027

  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

    teatrical®
    Night

    SKIN LIGHTENING
    CREAM

    Hydroquinone 2%

    Lightens dark (brownish) spots
    Improves skin appearance

    NET WT 50 g (1.7 oz)

    PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TEATRICAL SKIN LIGHTENING   SKIN LIGHTENER
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)  
    .Beta.-Carotene (UNII: 01YAE03M7J)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-055-011 in 1 CARTON10/23/2014
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart358A10/23/2014
    Labeler - Genomma Lab USA Inc. (832323534)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(50066-055)
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