Label: BODY FADE CREME MAXIMUM STRENGTH- hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 8, 2009

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  • ACTIVE INGREDIENT


    Active Ingredient

    Hydroquinone 2%

  • PURPOSE


    Purpose

    Skin Lightener Cream

  • INDICATIONS & USAGE


    Uses

    For gradual fading of dark (brownish) spots.

  • WARNINGS




    Warnings

    Avoid contact with eyes.


  • DO NOT USE

    Do not use on children under 12 years of age.

  • STOP USE

    Some users may experience a mild irritation. If skin Irritation becomes severe, stop use and consult a doctor.

  • DOSAGE & ADMINISTRATION


    Directions

    Apply all over your body twice daily. Pay special attention to problem areas like knees and elbows.

  • INACTIVE INGREDIENT


    Inactive Ingredients

    Water (Aqua), Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Cetyl Alcohol, DEA-Cetyl Phosphate, glycerin, Dimethicone, Tocopheryl Acetate, Sodium PCA, Aloe Barbadensis Leaf Extract, Citrus Unshiu Peel Extract, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, Polyacrylamide, Hydroxyethylcellulose, Fragrance, C13-14 Isoparaffin, Laureth-7, EDTA, Sodium Sulfite, Sodium Metabisulfite, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Blue 1 (CI 42090), Yellow 5 (CI 19140)

  • PRINCIPAL DISPLAY PANEL

    Image of Carton

  • INGREDIENTS AND APPEARANCE
    BODY FADE CREME  MAXIMUM STRENGTH
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-304-631 in 1 CARTON
    1180 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35412/08/2009
    Labeler - Biocosmetic Reasearch Labs (078870292)
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