Label: SYMBA SKIN LIGHTENING- 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 18, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hydroquinone 1.9%

  • Purpose

    Skin Lightening Agent

  • Uses

    Gradually lightens uneven and dark discoloration. Fades freckles, age, and liver spots. Moisturizes the skin. Leaves skin perfumed, soft, and smooth.

  • Warnings

    For external use only

    Do not use

    • on irritated or broken skin
    • on children under 12 years old
    • to prevent sunburn
    • in combination with products containing Resorcinol, Phenol, or Salicylic Acid

    When using this product

    • mild irritation or temporary skin darkening may occur
    • avoid contact with eyes
    • avoid unnecessary sun exposure

    Stop use and consult a doctor if

    • darkening persists
    • irritation becomes severe

    If pregnant or breast feeding, consult a doctor before use.

    KEEP OUT OF REACH OF CHILDREN. If swallowed, call poison control or get medical attention immediately.

  • Directions

    • for sensitive skin, test overnight on a small section of skin inside the elbow before use
    • apply a thin layer to skin on affected areas
    • use sunscreen to prevent darkening from recurring
    • use twice daily for at least 6 weeks or as directed by doctor
  • Inactive Ingredients

    Water (Aqua), Glyceryl Monostearate, Propylene Glycol, Papaya Extract (Carica Papaya Fruit Extract), Mineral Oil(Paraffinum Liquidum), Cetyl Palmitate, Isopropyl Myristate, Dimethicone, Sodium Lauryl Sulphate, Allantoin, Fragrance (Parfum), Sodium Metabisulfite, Ascorbic Acid (Vitamin C), Propylparaben, Edetate Disodium, FD&C Yellow 5.

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

    SYMBA®
    SKIN LIGHTENING CREAM
    PAPAYA

    NDC 71607-200-01

    With Papaya Fruit Extract, Vitamin A, and Vitamin E

    Principal Display Panel - 57 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SYMBA SKIN LIGHTENING 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71607-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE19 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    GlyceryL 1-Stearate (UNII: 258491E1RZ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Papaya (UNII: KU94FIY6JB)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium lauryl Sulfate (UNII: 368GB5141J)  
    Allantoin (UNII: 344S277G0Z)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C Yellow NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71607-200-011 in 1 CARTON10/12/2017
    1NDC:71607-200-5757 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 FINALpart358A10/12/2017
    Labeler - Craig Doura LLC (079084370)
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