Label: SKINMD LABORATORIES REVIGE L- dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71974-010-01, 71974-010-02 - Packager: Reviresco Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 24, 2019
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Glycerin, Cyclopentasiloxane, Cyclohexasiloxane, 1,2-Hexanediol, Butylene Glycol, PEG-32, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Hydrolyzed Collagen, Camellia Japonica Flower Extract, Citrus Limon (Lemon) Fruit Extract, Prunus Serrulata Flower Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Malva Sylvestris (Mallow) Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Portulaca Oleracea Extract, Primula Veris Extract, Veronica Officinalis Extract, Caesalpinia Sappan Bark Extract, Magnolia Obovata Bark Extract, Terminalia Chebula Fruit Extract, Citrus Unshiu Peel Extract, Moringa Pterygosperma Seed Extract, Thermus Thermophillus Ferment, Rhodiola Sacra Root Extract, Niacinamide, Panthenol, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, PEG-7 Dimethicone, Sodium Chloride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Dimethicone Crosspolymer, Caprylyl Glycol, Ethyl Hexanediol, Adenosine, Ethylhexylglycerin, Sodium Citrate, Betaine, Tocopheryl Acetate, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Biosaccharide Gum-1, Beta-Glucan, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum)
- PURPOSE
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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
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INGREDIENTS AND APPEARANCE
SKINMD LABORATORIES REVIGE L
dimethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71974-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 1.61 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71974-010-02 1 in 1 CARTON 12/01/2017 1 NDC:71974-010-01 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/01/2017 Labeler - Reviresco Co., Ltd. (693937110) Registrant - Reviresco Co., Ltd. (693937110) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(71974-010)