Label: ASHWAGANDHA FERMENT MASK- glycerin mask liquid

  • 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 May 8, 2019

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

  • ACTIVE INGREDIENT

    Glycerin (4.525%) - Skin Protectact

    Allantoin (0.1%) - Skin Protectact

  • INACTIVE INGREDIENT

    Water, Niacinamide, Propylene Glycol, Withania Somnifera Root Extract, Morus Bombycis Stem Extract, Butylene Glycol, Hydroxyethylcellulose, Aristoflex AVC, Chlorphenesin, Polyoxyethylene Hydrogenated Castor Oil, Aloe barbadensis Leaf Extract, Moringa Oleifera Seed Oil, Sodium Hyaluronate, Cetyl Ethylhexanoate, Moringa Pterygosperma Seed Extract, Adenosin, Polydimethylsiloxane, Phenoxyethanol, Squalane, Camellia Sinensis Leaf Extract, Coptis Chinensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Schizandra Chinensis Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance, Propolis Wax, Codonopsis Lanceolata Root Extract, Ficus Carica (Fig) Fruit Extract, Punica Granatum Fruit Extract, Caprylyl Glycol, 1,2-Hexanediol, Ethyl Hexanediol, Tert-Butanol, Particulate Not Otherwise Regulated (PNOR), Centella Asiatica Extract, PEG-60 Hydrogenated Castor Oil, Ethylhexylglycerin

  • PURPOSE

    Skin Protectact

  • WARNINGS

    1. Discontinue use if the following signs of irritation develop during using the cosmetics, and consult your dermatologist. If you keep using, it will aggravate the symptoms.
    1) Rashes, swell, itching, or irritation during using
    2) Such irritations as above in the applied spot due to an exposure to direct sunlight


    2. Do not apply in the area of cut, eczema, or dermatitis.


    3. Warning
    1) Keep out of reach of children.
    2) Keep out of places exposed to the direct sunlight and too hot or too cold places.

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    [How to use]

    1. After cleansing face, adjust the skin with the toner and applying (step1)Modam Moringa pure
    vitamin C ampoule to the whole face.
    2. Attach the mask sheet(step2) to the face properly.
    3. Take a relax for about 15~25 minutes and remove the mask sheet.
    4. After removing the mask sheet, gently massage and tap the skin for the remaining essence of the mask to be absorbed.

    # It is most effective to use intensively in consideration of the skin turnover cycle of 4 weeks.

  • DOSAGE & ADMINISTRATION

    Attach this product to the skin for 15-25 minutes and remove the supporter and evenly spread the remaining substances to the skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASHWAGANDHA FERMENT MASK 
    glycerin mask liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72540-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.131 g  in 25 mL
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.025 g  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Niacinamide (UNII: 25X51I8RD4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Moringa Oleifera Seed Oil (UNII: REM6A5QMC0)  
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Squalane (UNII: GW89575KF9)  
    Propolis Wax (UNII: 6Y8XYV2NOF)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72540-004-025 in 1 PACKAGE05/08/2019
    1NDC:72540-004-0125 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/08/2019
    Labeler - MODAM KOREA (693842277)
    Registrant - MODAM KOREA (693842277)
    Establishment
    NameAddressID/FEIBusiness Operations
    MODAM KOREA693842277manufacture(72540-004)