Label: ALA-C CELL CLINIC SOLUTION - glycerin 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 September 3, 2015

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  • ACTIVE INGREDIENT

    glycerin


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  • INACTIVE INGREDIENT

    water, allantoin, etc.


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  • PURPOSE

    whitening


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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

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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
    ALA-C CELL CLINIC SOLUTION 
    glycerin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70091-1001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70091-1001-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 09/03/2015
    Labeler - DAOOMCOSTECH.co.Ltd. (688258273)
    Registrant - DAOOMCOSTECH.co.Ltd. (688258273)
    Establishment
    Name Address ID/FEI Business Operations
    DAOOMCOSTECH.co.Ltd. 688258273 manufacture(70091-1001)
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