Label: BIOXIDEA MIRACLE 48 EXCELLENCE GOLD MASK- allantoin gel

  • 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 3, 2014

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  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Aqua/Water/Eau, Aloe Barbadensis Leaf Extract, Glycerin, Dipropylene Glycol, Citrus Unshiu Peel Extract, Butylene Glycol, Niacinamide, Algae Extract, Camellia Sinensis Leaf Extract, Chondrus Crispus (Carrageenan), Ceratonia Siliqua Gum, Cyamopsis Tetragonoloba (Guar) Gum, Glucose, Glycine Soja Phytoplacenta Extract, Colloidal Gold, Acetyl Hexapeptide-8, Potassium Chloride, Rose Extract, 1,2-Hexanediol, Ubiquinone, Pearl Powder, Collagen, Tocopheryl Acetate, Rosa Centifolia Flower Water, Punica Granatum Fruit Extract, Lactobacillus/Aloe Barbadensis Ferment Filtrate, Disodium EDTA, Adenosine, Snail Secretion Filtrate, Mica, Chamomilla Recutita (Matricaria) Extract, Fragrance/Parfum

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications and Usage: After cleansing, place mask on your face. Leave it on for 20-30 minutes. Gently remove the mask and lightly massage any remaining serum into your skin. Do not rinse.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration: Use at least twice a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BIOXIDEA MIRACLE 48 EXCELLENCE GOLD MASK 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69133-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.15 g  in 3 
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69133-020-013 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2014
    Labeler - Cosmetics Institute Technology Co., Ltd. (690081646)
    Registrant - Cosmetics Institute Technology Co., Ltd. (690081646)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetics Institute Technology Co., Ltd.690081646manufacture(69133-020)
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