SKINMD LABORATORIES REVIGE L- dimethicone gel

SKINMD LABORATORIES REVIGE L by

Drug Labeling and Warnings

SKINMD LABORATORIES REVIGE L by is a Otc medication manufactured, distributed, or labeled by Reviresco Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Dimethicone 3.22%

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

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:

After facial wash, apply an adequate amount on the damaged skin caused by laser treatment or UV rays. Apply twice a day on normal skin, morning and night, at the last stage of skin care. Tap gently for max absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINMD LABORATORIES REVIGE L 
dimethicone gel

Product 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)