SKINMD LABORATORIES PURE WHITENOL SERUM- tranexamic acid cream
Reviresco Co., Ltd.

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.

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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 moisturizing

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 moisturizing

Directions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

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)

Revised: 12/2017
Document Id: 74ec3ee6-af0f-4f64-bbf7-d0749bd9643e
Set id: e451eac7-c186-4df2-a1e4-1bfd3dcef557
Version: 1
Effective Time: 20171228
Reviresco Co., Ltd.