Label: SKINMD LABORATORIES PURE WHITENOL INTENSIVE- tranexamic acid, adenosine cream

  • NDC Code(s): 71974-020-01, 71974-020-02
  • Packager: Reviresco Co., Ltd.
  • 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 December 28, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Tranexamic acid 0.2%, Adenosine 0.04%

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  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Butylene Glycol, Glycerin, Octyldodecyl Myristate, Hydrogenated Poly(C6-14 Olefin), Limnanthes Alba (Meadowfoam) Seed Oil, Mineral Oil, Borago Officinalis Seed Oil, Rhodiola Sacra Root Extract, Cordyceps Sinensis Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxypropyl Bispalmitamide MEA, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Cyclopentasiloxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Arginine, Cyclohexasiloxane, Dextrin, Lecithin, Caprylyl Glycol, Tocopheryl Acetate,4-Butylresorcinol, Squalane, Trehalose, Phytosphingosine, Polysorbate 80, Sodium Hyaluronate, Sorbitan Oleate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

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  • PURPOSE

    Purpose: Anti wrinkle

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  • WARNINGS

    Warnings: 1. Discontinue use if the following symptoms occur. If symptoms are extreme consult a dermatologist. 1) Symptoms such as red dots, swollenness, itching, stimulation during use. 2) Symptoms such as the ones mentioned in 1) occur on the applied area. 2. Do not apply to parts of the skin that have rashes, are cut, or are infected. 3. Directions for storage and handling. 1) The lid must be closed after use. 2) Keep out of reach of babies and children. 3) Store in a cool and dry place and avoid exposure to direct sunlight.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children.

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  • Uses

    Uses: For anti-wrinkle

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  • Directions

    Directions: Apply two times at morning and night onto the skin daily.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SKINMD LABORATORIES PURE WHITENOL INTENSIVE 
    tranexamic acid, adenosine cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71974-020
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tranexamic acid (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) Tranexamic acid 0.02 g  in 10 mL
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine 0.004 g  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71974-020-02 1 in 1 CARTON 12/01/2017
    1 NDC:71974-020-01 10 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/01/2017
    Labeler - Reviresco Co., Ltd. (693937110)
    Registrant - Reviresco Co., Ltd. (693937110)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmax, Inc. 689049693 manufacture(71974-020)
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