Label: ULTRA GLOW FADE- hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL

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 10, 2018

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  • ACTIVE INGREDIENT

    2% Hydroquinone ..... Skin Lightener

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Skin lightener

  • INDICATIONS & USAGE

    Ultra Glow Fade Cream

    2% Hydroquinone  ......  Skin Lightener

  • WARNINGS

    Warnings:

    For external use only. Children under 12 years of age: Do not use unless directed by a doctor. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Avoid contact with eyes, rinse with water to remove. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin during and after treatment is completed in order to prevent darkening from reoccurring. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults: Apply a small amount in a thin layer on the affected area twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable on very dark skin.

  • OTHER SAFETY INFORMATION

    Other Information: Protect the product in this container from excessive heat and direct sun. For expiration date, please see bottom of jar.

    Distributed by 

    KEYSTONE LABORATORIES © 2013

    www.keystone-labs.com

    1-800-772-8860  / Memphis, TN 38101-2026

    MADE IN U.S.A.

    PM-LB 0011

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aqua/Water/Eau, Stearyl Stearate, Glycerol Stearate, Propylene Glycol Alcohol, Isopropyl Myristate, Sodium Metabisulfite, Fragrance, Sodium Sulfite, Steareth 20, Methyl Paraben, Buthydroxytoluene, Propyl Gallate, Tetrasodium EDTA, Propyl Paraben, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ULTRA GLOW FADE 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58318-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1 g  in 51 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58318-003-0151 g in 1 CANISTER; Type 0: Not a Combination Product01/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/10/2018
    Labeler - Keystone Laboratories (007017429)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keystone Laboratories007017429manufacture(58318-003)
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