Label: REFACE TOX AMPULE- niacinamide, adenosine solution

  • Category: HUMAN OTC DRUG LABEL

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 June 28, 2021

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  • ACTIVE INGREDIENTS

    Niacinamide 2.0%, Adenosine 0.04%

  • INACTIVE INGREDIENTS

    Water, Butylene Glycol, Glycerin, Protease, 1,2-Hexanediol, Beta-Glucan, Bifida Ferment Lysate, Scutellaria Baicalensis Root Extract, Illicium Verum (Anise) Fruit Extract, Arginine, Carbomer, Gentiana Scabra Root Extract, Cynara Scolymus (Artichoke) Bud Extract, Pteris Multifida Extract, Camellia Sinensis Leaf Extract, Luffa Cylindrica Fruit Extract, Allium Sativum (Garlic) Bulb Extract, Psidium Guajava Leaf Extract, Psidium Guajava Fruit Extract, Foeniculum Vulgare (Fennel) Leaf Extract, Momordica Charantia Extract, Spirulina Platensis Extract, Salvia Officinalis (Sage) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Selaginella Tamariscina Extract, Gynostemma Pentaphyllum Extract, Sodium Hyaluronate, Dioscorea Japonica Root Extract, Hydrolyzed Corn Starch, Allantoin, Betaine, Sucrose

  • PURPOSE

    Skin Brightening, Anti Wrinkle

  • WARNINGS

    Avoid contact with eyes.
    Discontinue use if signs of irritation or rashes appear and consult with the dermatologist if symptoms persist.
    Do not use on wounds, animal bites or serious burn.
    Keep out of reach of children.
    Keep away from direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    ■ This solution controls forming wrinkle with Korea patented cosmetic composition “RealTox”.
    ■ Helps improve the brightness skin tone
    ■ Helps reduce the appearance of fine lines and wrinkles

  • Directions

    ■ Apply the adequate amount on face and cover up face with hands to be absorbed

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    REFACE TOX AMPULE 
    niacinamide, adenosine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72729-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.07 g  in 3.5 mL
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.001 g  in 3.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72729-030-024 in 1 CARTON10/01/2018
    1NDC:72729-030-013.5 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2018
    Labeler - Woorhi Mechatronics Co., Ltd. (557837985)
    Registrant - Woorhi Mechatronics Co., Ltd. (557837985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ester Co., Ltd.688425766manufacture(72729-030)