Label: PURE WHITENOL SERUM- tranexamic acid cream

  • 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 March 6, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients: Tranexamic Acid 0.1%

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycerin, Octyldodecyl Myristate, Hydrogenated Poly(C6-14 Olefin), Limnanthes Alba (Meadowfoam) Seed Oil, Mineral Oil, Borago Officinalis Seed Oil, Rhodiola Sachalinensis Extract, Morus Alba Root Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxy-propyl Bispalmitamide MEA, Cyclopentasil-oxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasil-oxane, Dextrin, Lecithin, Isohexadecane, Caprylyl Glycol, Tocopheryl Acetate, Trehalose, Arginine, Polysorbate-80, 4-n-butylresorcinol, Squalane, Sodium Hyaluronate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

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  • PURPOSE

    Purpose: Skin Protectant / Brightening

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  • WARNINGS

    Warnings:

    1. Discontinue use it 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 from 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 children: Keep out of reach of babies and children

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  • INDICATIONS & USAGE

    Indications & Usage: For skin lightening. Apply adequate amount following the skin texture and gently tap to enhance absorption.

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  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply two times at morning and night onto the skin daily.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

    Image of carton

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  • INGREDIENTS AND APPEARANCE
    PURE WHITENOL SERUM 
    tranexamic acid cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69629-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tranexamic Acid (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) Tranexamic Acid 0.05 mg  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69629-010-01 50 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/01/2015
    Labeler - SKIN M.D. KOREA (688278970)
    Registrant - SKIN M.D. KOREA (688278970)
    Establishment
    Name Address ID/FEI Business Operations
    SKIN M.D. KOREA 688278970 manufacture(69629-010)
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