Label: ULTRA GLOW FADE- hydroquinone cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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

  • ACTIVE INGREDIENT

    2% Hydroquinone ..... Skin Lightener

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • PURPOSE

    Skin lightener

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  • INDICATIONS & USAGE

    Ultra Glow Fade Cream

    2% Hydroquinone  ......  Skin Lightener

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  • 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.

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  • 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.

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  • 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

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    water, stearyl stearate, propylene glycol, cetyl alcohol, isopropyl myristate, sodium metabisulfite, fragrance, steareth 20, methylparaben, methyl alcohol, propylis gallas, sodium sulfite, tetrasodium EDTA, propylparaben, citric acid.

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  • INGREDIENTS AND APPEARANCE
    ULTRA GLOW FADE 
    hydroquinone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58318-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 1 g  in 51 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERYL MONOSTEARATE  
    SODIUM LAURYL SULFATE  
    PROPYLENE GLYCOL  
    ISOPROPYL MYRISTATE  
    CETYL ALCOHOL  
    SODIUM DITHIONATE  
    STEARYL STEARATE  
    STEARETH-20  
    METHYLPARABEN  
    PROPYLPARABEN  
    BUTYLATED HYDROXYTOLUENE  
    PROPYL GALLATE  
    SODIUM SULFITE  
    EDETATE DISODIUM  
    CITRIC ACID MONOHYDRATE  
    METHYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58318-003-01 51 g in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 04/07/1964
    Labeler - Keystone Laboratories (007017429)
    Establishment
    Name Address ID/FEI Business Operations
    Keystone Laboratories 007017429 manufacture(58318-003)
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