Label: IMAGE MD LIGHTENING RX- 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 July 29, 2010

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    INDICATIONS AND USAGE SECTION:

    For Physician Dispensary Only


    An effective lightening creme that diminish facial and body discolorations.


    DIRECTIONS:

    Apply to affected areas in the evening. Apply a sunblock during the day, or as directed by a physician.

    Paraben-free

    Contains Vitamin C and E
  • ACTIVE INGREDIENT


    ACTIVE INGREDIENTS:

    Hydroquinone 4%

  • INACTIVE INGREDIENT


    INACTIVE INGREDIENTS:

    Water, Glyceryl Monostearate, Polyoxyl 100 Stearate, Butylene Glycol, Stearyl Alcohol, Stearic Acid, Caprylic and Capric Triglyceride, Linoleic Acid, Soy Phospholipids, Dimethicone, C12-15 Alkyl Benzoate, Xanthan Gum, Magnesium Aluminum Silicate, Cetyl Alcohol, Stearyl Alcohol, Glycerin, Licorice, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Lactic Acid, Disodium EDTA, Dipotassium Glycyrrizinate, Vitamin E, Sodium Metabisulfite, Fragrance-Orange.

  • WARNINGS


    WARNING:

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children


  • PRINCIPAL DISPLAY PANEL

    DISTRIBUTOR:

    Image International

    Palm Beach, FL 33411 USA


    IMAGE OF PRINCIPAL DISPLAY PANEL:


    Image of the product: IMAGE MD Lightening Ceme Rx



  • INGREDIENTS AND APPEARANCE
    IMAGE MD LIGHTENING RX 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4046-129.6 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35801/01/2010
    Labeler - Allure Labs, Inc. (926831603)