Label: SKIN LIGHTENING COMPLEX- 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 September 2, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Hydroquinone (2.0%)

  • Purpose

    skin lightener

  • Indications

    • reduce dark blotches and spots
    • even out skin tone and reduce skin discoloration
  • Warnings

    For external use only

    Avoid eye contact

    Discontinue use if irritation occurs

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

  • Directions

    • Apply a thin coat to the affected area twice daily or as directed by your physician
    • Utilize sunscreen daily
  • Inactive Ingredients

    Aqua (Water), Glycolic Acid, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Stearyl Alcohol, C12-C15 Alkyl Benzoate, Hydroxypropyl Starch Phosphate, Dimethicone, Sodium Hydroxide, Myristyl Alcohol, Glyceryl Stearate, Butyl Octyl Salicylate, Myristyl Glucoside, PEG 100 Stearate, Lactic Acid, Dehydroxanthan Gum, Sodium Metabisulfite, Camellia Oleifera Leaf Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Propylene Glycol, Phenoxy ethanol, Glycyrrhiza Glabra (Licorice) Root Extract, Arctostaphylos Uva Ursi Leaf Extract, Tocopheryl Acetate, BHT, Diazolidinyl Urea, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Disodium EDTA.

  • Other Information

    • Read directions and warnings before use
    • Store at room temperature 68°-77° F (20°-25° C)
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    A&D Pharma LLC

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Label

    A&D
    pharma

    Skin
    Lightening
    Complex
    with GLYCOLIC ACID

    30 g

    Principal Display Panel - 30 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SKIN LIGHTENING COMPLEX 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-8401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (PHENOL - UNII:339NCG44TV) HYDROQUINONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Myristyl Alcohol (UNII: V42034O9PU)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Polyoxyl 100 Stearate (UNII: YD01N1999R)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Glycyrrhiza Glabra (UNII: 2788Z9758H)  
    Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Ethylparaben (UNII: 14255EXE39)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65113-8401-130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A12/09/2009
    Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE
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