Label: PURIFACE SPIRULINA EYE GEL MASKS- spirulina platensis extract, allantoin patch

  • 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 February 8, 2019

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

  • Active ingredients

    Allantoin

    Spirulina Platensis Extract

  • Purpose

    Skin protectant

  • Uses

    Moisturizes skin.

  • Warnings

    For external use only

    Do not use when skin is red, inflamed, irritated, or painful

    When using this product

    - do not apply on other parts of the body avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

    - do not apply directly to wound or open cut

    Stop use and ask a doctor if

    - Rash or irritation on skin develops and lasts

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Simply wash and dry your skin thoroughly. Before applying the gel under each eye, remove clear plastic from each gel. You may use either side of the gel. Allow gel to work for 15-20 minutes. Remove each gel and lightly massage any remaining serum into your skin.

  • Inactive ingredients

    Water, Glycerin, Butylene Glycol, Ceratonia Siliqua (Carob) Gum, Sucrose, Sodium Hyaluronate, Ethylhexylglycerin, Hydrolyzed Collagen, Simmondsia Chinensis (Jojoba) Seed Oil, Euterpe Oleracea Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Vitis Vinifera (Grape) Vine Extract, Carrageenan, Potassium Chloride, Xanthan Gum, Cellulose Gum, Sodium Polyacrylate, Dipotassium Glycyrrhizate, Gellan Gum, Calcium Lactate, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Chlorphenesin, Propanediol, Pentylene Glycol, Cocos Nucifera (Coconut) Fruit Extract, Pinus Sylvestris Leaf Extract, Ethyl Hexanediol, 1,2-Hexanediol

  • Puriface Spirulina Eye Gel Masks

    eye gel masks draft label with drug facts panel

  • INGREDIENTS AND APPEARANCE
    PURIFACE SPIRULINA EYE GEL MASKS 
    spirulina platensis extract, allantoin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71727-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0864 g  in 27 mL
    SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE) (SPIRULINA PLATENSIS - UNII:9L3TIH1UUE) SPIRULINA PLATENSIS0.0675 g  in 27 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71727-104-021 in 1 BOX02/08/2019
    1NDC:71727-104-0127 mL in 1 POUCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/08/2019
    Labeler - iMode Korea, Inc. (694627846)
    Registrant - iMode Korea, Inc. (694627846)
    Establishment
    NameAddressID/FEIBusiness Operations
    JINCOSTECH Co., Ltd.688484870manufacture(71727-104)
    Establishment
    NameAddressID/FEIBusiness Operations
    iMode Korea, Inc.694627846relabel(71727-104)