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SKINMD LABORATORIES PURE WHITENOL INTENSIVE

Medically reviewed on December 28, 2017

Dosage form: cream
Ingredients: Tranexamic acid 0.02g in 10mL, Adenosine 0.004g in 10mL
Labeler: Reviresco Co., Ltd.
NDC Code: 71974-020

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 0.2%, 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

SKINMD LABORATORIES PURE WHITENOL INTENSIVE 
tranexamic acid, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71974-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tranexamic acid (TRANEXAMIC ACID) Tranexamic acid0.02 g  in 10 mL
Adenosine (ADENOSINE) Adenosine0.004 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Butylene Glycol 
Packaging
#Item CodePackage Description
1NDC:71974-020-021 TUBE in 1 CARTON
1NDC:71974-020-0110 mL in 1 TUBE
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/FEIOperations
Cosmax, Inc.689049693manufacture(71974-020)

 
Reviresco Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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