Label: ESSENTIAL FADE COMPLEX- hydroquinone gel gel

  • 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 January 20, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Hydroquinone 2%

  • PURPOSE

    Purpose

    Skin Lightener Gel

  • INDICATIONS & USAGE

    Use For gradual fading of dark (brownish) spots.

  • WARNINGS

    Warnings

    Avoid contact with eyes. Children under 12 years of age: do not use unless directed by a doctor. Some users may experience a mild irritation. If skin irritation becomes severe, stop use and consult a doctor.

  • DOSAGE & ADMINISTRATION

    Directions Apply a small amount as a thin layer on the affected area or use as directed by a doctor. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent or protective clothing in order to prevent darkening from reoccurring.

  • INACTIVE INGREDIENT

    Other Ingredients

    Water, Propylene Glycol, Cyclomethicone, Dimethiconol, Soybean (Glycine Soja) Oil, Ethylhexyl Cocoate, Butylene Glycol, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Dimethicone, Citrus Unshiu Peel Extract, Lecithin, Retinol, Glycolipids, Glycerin, Hydroxyethylcellulose, EDTA, Sodium Metabisulfite, Sodium Sulfite, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Fragrance, Yellow 5,  Green 5.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    image of efadec

  • INGREDIENTS AND APPEARANCE
    ESSENTIAL FADE COMPLEX 
    hydroquinone gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-318-151 in 1 CARTON
    115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/20/2011
    Labeler - Biocosmetics Research Lab (078870292)
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