SKINMD LABORATORIES PURE WHITENOL INTENSIVE- tranexamic acid, adenosine 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 0.2%, Adenosine 0.04%

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 Sacra Root Extract, Cordyceps Sinensis Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxypropyl Bispalmitamide MEA, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Cyclopentasiloxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Arginine, Cyclohexasiloxane, Dextrin, Lecithin, Caprylyl Glycol, Tocopheryl Acetate,4-Butylresorcinol, Squalane, Trehalose, Phytosphingosine, Polysorbate 80, Sodium Hyaluronate, Sorbitan Oleate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)

PURPOSE

Purpose: Anti wrinkle

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 anti-wrinkle

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 INTENSIVE 
tranexamic acid, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71974-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tranexamic acid (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) Tranexamic acid0.02 g  in 10 mL
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.004 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71974-020-021 in 1 CARTON12/01/2017
1NDC:71974-020-0110 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2017
Labeler - Reviresco Co., Ltd. (693937110)
Registrant - Reviresco Co., Ltd. (693937110)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(71974-020)

Revised: 12/2019
Document Id: 141d126f-70b2-465c-9317-082bd3eb9f49
Set id: 7b9adc93-0d15-48d5-90f4-462d95643349
Version: 3
Effective Time: 20191224
 
Reviresco Co., Ltd.