Label: BLACK CAVIDIOL 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 June 24, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Propanediol, Methylpropanediol, Butylene Glycol, Caviar Extract, Pearl Powder, Hydroxyethylcellulose, Glyceryl Acrylate/Acrylic Acid Copolymer, Propylene Glycol, PVM/MA Copolymer, Trehalose, Carbomer, Arginine, Disodium EDTA, Allantoin, Dipotassium Glycyrrhizate, Sodium Hyaluronate, Chlorphenesin, Glycyrrhiza Glabra (Licorice) Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Schizandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Zingiber Officinale (Ginger) Root Extract, Camellia Sinensis Leaf Extract, Citrus Grandis (Grapefruit) Seed Extract, Acorus Calamus Root Extract, Perilla Ocymoides Leaf Extract, Agar, Xanthan Gum, Algin, Phenoxyethanol, Iron Oxides, Hydrolyzed Keratin

  • 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) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures or sun. 4. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & usage: 1) Apply a Black Cavidiol Mask onto clean skin and align it evenly onto the face. 2) Pull the bottom of the mask upward and align it evenly with the chin. 3) Remove after 10-20 minutes and lightly tap the skin until the serum is fully absorbed.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: Every day or every other day

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BLACK CAVIDIOL MASK 
    allantoin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70768-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.2 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70768-010-021 in 1 CARTON05/01/2016
    1NDC:70768-010-0140 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2016
    Labeler - ZEMNA COMPANY CO., Ltd (689846931)
    Registrant - ZEMNA COMPANY CO., Ltd (689846931)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZEMNA COMPANY CO., Ltd689846931manufacture(70768-010)