Label: ADVANCED DUAL COMPLEX FADE MAXIMUM STRENGTH PLUS- hydroquinone gel

  • NDC Code(s): 59735-310-28
  • Packager: Biocosmetic Research Labs
  • 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 February 25, 2009

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  • ACTIVE INGREDIENT


    Active Ingredient:

    Hydroquinone 2%

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  • PURPOSE


    Purpose:

    Skin Lightening Gel

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  • INDICATIONS & USAGE


    Uses:

    For gradual fading of dark (brownish) spots

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  • WARNINGS


    Warnings:

    Avoid contact with eyes.  Children under 12 years of age; Do not use unless directed by a doctor.

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  • STOP USE

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

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  • 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 or a sun blocking agent.

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  • INACTIVE INGREDIENT


    Other Ingredients:

    Water, Propylene Glycol, Carbomer, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, glycerin, Citrus Unshiu Peel Extract, Sodium Hydroxymethylglycinate,Sodium Sulfite, Sodium Metabisulfite, Butylene Glycol, Phenoxyethanol, Disodium EDTA, Polysorbate 20, Trisodium EDTA, Benzophenone-4, EDTA, Caprylyl Glycol, Hexylene Glycol, Sodium Hydroxide, Caramel, Mica, Iron Oxides (CI 77491)

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  • INGREDIENTS AND APPEARANCE
    ADVANCED DUAL COMPLEX FADE  MAXIMUM STRENGTH PLUS
    hydroquinone gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-310
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 2 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59735-310-28 1 in 1 CARTON
    1 28.4 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358 02/25/2009
    Labeler - Biocosmetic Research Labs (078870292)
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