PURE WHITENOL SERUM (TRANEXAMIC ACID) CREAM [SKIN M.D. KOREA]

PURE WHITENOL SERUM (TRANEXAMIC ACID) CREAM [SKIN M.D. KOREA]
PDF | XML

NDC 69629-010-01
Set ID a46ac0e4-f657-4510-aaf1-ae1a52a5d670
Category HUMAN OTC DRUG LABEL
Packager SKIN M.D. KOREA
Generic Name
Product Class Antifibrinolytic Agent
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredients: Tranexamic Acid 0.1%

  • 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)

  • PURPOSE

    Purpose: Skin Protectant / Brightening

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children

  • INDICATIONS & USAGE

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

  • DOSAGE & ADMINISTRATION

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PURE WHITENOL SERUM 
    tranexamic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69629-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tranexamic Acid (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) Tranexamic Acid0.05 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69629-010-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2015
    Labeler - SKIN M.D. KOREA (688278970)
    Registrant - SKIN M.D. KOREA (688278970)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKIN M.D. KOREA688278970manufacture(69629-010)

Related Drugs