Label: BIOXIDEA ELEMENT 48 NATURA GOLD MASK- allantoin patch

  • 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 August 27, 2014

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  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Aqua/Water/Eau, Glycerin, Dipropylene Glycol, Butylene Glycol, Aloe Barbadensis Leaf Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Ceratonia Siliqua Gum, Beta-Glucan, Chondrus Crispus (Carrageenan), Algae Extract, Cyamopsis Tetragonoloba (Guar) Gum, Potassium Chloride, Glucose, Rose Extract, Dipeptide Diaminobutyroyl Benzylamide Diacetate, Pearl Powder, Collagen, Tocopheryl Acetate, Disodium EDTA, 1,2-Hexanediol, Ubiquinone, Adenosine, Chamomilla Recutita (Matricaria) Extract, Mica, Colloidal Gold, 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 ELEMENT 48 NATURA GOLD MASK 
    allantoin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69133-040
    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:69133-040-013 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(69133-040)
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