Label: AB DUO WHITENING A - glycerin solution

  • 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 December 8, 2014

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

  • ACTIVE INGREDIENT

    glycerin

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  • INACTIVE INGREDIENT

    water, arbutin, 1,2-hexanediol, licorice root ext, camellia sinensis leaf ext, centella asiatica ext

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  • PURPOSE

    skin whitening
    skin protectant

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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

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  • INDICATIONS & USAGE

    apply proper amount to the skin and massage

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  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・If the product gets into the eyes, don't rub but rinse with water.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


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  • DOSAGE & ADMINISTRATION

    for external use only

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  • INGREDIENTS AND APPEARANCE
    AB DUO WHITENING A 
    glycerin solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69422-3001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 10 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ARBUTIN (UNII: C5INA23HXF)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69422-3001-1 5 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/08/2014
    Labeler - General Bio Co., Ltd. (688299527)
    Registrant - General Bio Co., Ltd. (688299527)
    Establishment
    Name Address ID/FEI Business Operations
    General Bio Co., Ltd. 688299527 manufacture(69422-3001)
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