Label: SEOLHEUN REFRESH F5 MASK PACK- niacinamide and adenosine 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 July 14, 2020

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

  • ACTIVE INGREDIENT

    Niacinamide 2.00%--------------------Skin Protectant

    Adenosine 0.04%----------------------Skin Protectant

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    • Protects, restores and soothes the skin
    • Moisturize and nourish the skin
    • Enhances radiance and brightens skin
  • DOSAGE & ADMINISTRATION

    1. After washing your face, dry face thoroughly and apply toner.
    2. Remove mask from pouch and unfold.
    3. Aligning openings with eyes, nose and mouth, gently apply mask to face.
    4. Leave mask on for 10-20 minutes, then remove and pat skin gently to promote absorption

    of the essence.

  • WARNINGS

    For external use only

    Do not use on areas with wounds, eczema, or dermatitis.

    Stop use and ask a doctor if you have

    a. Redness, swelling, itchiness, irritation, or other similar symptoms.
    b. Occurrence of the above symptoms upon exposure to direct sunlight.

    When using this product, keep out of eyes. If eye contact occurs, rinse well with water.
    Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Propanediol, Trehalose, Betaine, Saccharomyces/Panax Ginseng Sprout Ferment Extract Filtrate, Carbomer, Tromethamine, Panthenol, Centella Asiatica (Gotu Kola) Extract, Hydroxyethylcellulose, Disodium EDTA, Sodium Hyaluronate, Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Leaf Extract, Rhodiola Rosea Root Extract, Rosa Damascena (Rose) Flower Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract..

  • OTHER SAFETY INFORMATION

    Do not store in areas with extreme heat or cold, or under direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    Seolheun Refresh F5 Mask Pack

  • INGREDIENTS AND APPEARANCE
    SEOLHEUN REFRESH F5 MASK PACK 
    niacinamide and adenosine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70889-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.5 g  in 25 g
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.01 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCYRRHIZA GLABRA WHOLE (UNII: M1F96IE0ZC)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    BETAINE (UNII: 3SCV180C9W)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ROSA DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70889-610-105 in 1 BOX07/14/2020
    125 g in 1 PACKAGE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/14/2020
    Labeler - Oneskin Cosmetics Co., Ltd. (689846630)
    Registrant - Oneskin Cosmetics Co., Ltd. (689846630)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oneskin Cosmetics Co., Ltd.689846630manufacture(70889-610)