PURE WHITENOL SERUM- tranexamic acid cream 
SKIN M.D. KOREA

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.

----------

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

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)

Revised: 3/2015
Document Id: 30a677f5-a7b7-47b0-962b-24b15369fc54
Set id: a46ac0e4-f657-4510-aaf1-ae1a52a5d670
Version: 1
Effective Time: 20150306
 
SKIN M.D. KOREA