SKINMD LABORATORIES REVIGE L- dimethicone gel 
Reviresco Co., Ltd.

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.

----------

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

Image of carton

SKINMD LABORATORIES REVIGE L 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71974-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.61 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71974-010-021 in 1 CARTON12/01/2017
1NDC:71974-010-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2017
Labeler - Reviresco Co., Ltd. (693937110)
Registrant - Reviresco Co., Ltd. (693937110)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(71974-010)

Revised: 12/2019
Document Id: 47e21f51-6ebc-4767-9045-3f78a86abaac
Set id: 48b38bae-0fd9-427e-8486-3b9c9832702e
Version: 3
Effective Time: 20191224
 
Reviresco Co., Ltd.