Label: PURE WHITENOL SERUM- tranexamic acid cream
- NDC Code(s): 69629-010-01
- Packager: SKIN M.D. KOREA
- 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.
Updated March 6, 2015
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- ACTIVE INGREDIENT
Active Ingredients: Tranexamic Acid 0.1%Close
- 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)Close
Purpose: Skin Protectant / BrighteningClose
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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children: Keep out of reach of babies and childrenClose
- INDICATIONS & USAGE
Indications & Usage: For skin lightening. Apply adequate amount following the skin texture and gently tap to enhance absorption.Close
- DOSAGE & ADMINISTRATION
Dosage & Administration: Apply two times at morning and night onto the skin daily.Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Image of carton
- 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)