NDC | 71974-020-01, 71974-020-02 |
Set ID | 7b9adc93-0d15-48d5-90f4-462d95643349 |
Category | HUMAN OTC DRUG LABEL |
Packager | Reviresco Co., Ltd. |
Generic Name | |
Product Class | Adenosine Receptor Agonist, Antifibrinolytic Agent |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
-
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
-
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
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SKINMD LABORATORIES PURE WHITENOL INTENSIVE
tranexamic acid, adenosine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71974-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tranexamic acid (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) Tranexamic acid 0.02 g in 10 mL Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine 0.004 g in 10 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:71974-020-02 1 in 1 CARTON 12/01/2017 1 NDC:71974-020-01 10 mL in 1 TUBE; 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(71974-020)