SKINMD LABORATORIES PURE WHITENOL SERUM- tranexamic acid cream

SKINMD LABORATORIES PURE WHITENOL SERUM by

Drug Labeling and Warnings

SKINMD LABORATORIES PURE WHITENOL SERUM by is a Otc medication manufactured, distributed, or labeled by Reviresco Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Tranexamic acid 0.1%

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 Sachalinensis Extract, Morus Alba Root Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxypropyl Bispalmitamide MEA, Cyclopentasiloxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Dextrin, Lecithin, Isohexadecane, Caprylyl Glycol, Tocopheryl Acetate, 4-Butylresorcinol, Trehalose, Arginine, Polysorbate 80, Squalane, Sodium Hyaluronate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

PURPOSE

Purpose: Skin Whitening

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

Uses

Uses: For skin Whitening

Directions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINMD LABORATORIES PURE WHITENOL SERUM 
tranexamic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71974-030
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 g  in 50 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: 71974-030-02	1 in 1 CARTON	12/01/2017
1	NDC: 71974-030-01	50 mL in 1 BOTTLE, PUMP; 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(71974-030)