Label: SKINMD LABORATORIES REVIGE L- dimethicone gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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

    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

  • INGREDIENTS AND APPEARANCE
    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)