Label: AQUA BAB MODELING MASK- glycerin, niacinamide, allantoin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 19, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 5.00%, Niacinamide 1.00%, Allantoin 0.20%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Article 1: Aqua, Glucose, PEG-75, Algin, Butylene Glycol, Potassium Chloride, Morus Alba Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Centella Asiatica Extract, Zingiber Officinale (Ginger) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Chinensis Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Caprylyl Glycol, 1,2-Hexanediol, PEG-60 Hydrogenated Castor Oil, Trisodium Phosphate, Tetrasodium Pyrophosphate, Cellulose Gum, Hydrolyzed Collagen, Dioscorea Japonica Root Extract, Achillea Millefolium Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Lanolin Oil, Phytosphingosine, Ceramide 3, Squalane, Phospholipids, Phytosterols, Beta-Sitosterol, Polysorbate 20, Tropolone, rh-Oligopeptide-1, Panax Ginseng Callus Culture Extract, Disodium EDTA, Flavor

    Article 2:Glucose, Calcium Sulfate, Hibiscus Sabdariffa Flower, Malpighia Emarginata (Acerola) Fruit Extract, Gardenia Yellow + Gardenia Blue, Aloe Barbadensis Leaf Powder, Zea Mays (Corn) Starch

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 2. Do not use the product on an open skin wound or on areas of eczema or infection. 3. Storage and handling instructions 1) Keep out of reach of children. 2) Avoid exposure to high or low temperatures or sun. 4. Avoid contact with eyes.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • How to use

    How to use: 1) Mix the crystal gel packet & the powder pack together in the mixing bowl. 2) Stir the mixture with the spatula well until completely mixed 3) Using the spatula, apply evenly over the entire face. 4) After about 20minutes, remove the mask, gently peeling in the upward direction starting at the bottom. 5) Lightly tap the remaining essence on the skin to allow full absorption

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Every day or every other day

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    AQUA BAB MODELING MASK 
    glycerin, niacinamide, allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70768-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin10 g  in 220 g
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.2 g  in 220 g
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.04 g  in 220 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70768-030-01220 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2016
    Labeler - ZEMNA COMPANY CO., Ltd (689846931)
    Registrant - ZEMNA COMPANY CO., Ltd (689846931)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZEMNA COMPANY CO., Ltd689846931manufacture(70768-030)