Label: GMC MEDICAL ACNE- salicylic acid gel

  • NDC Code(s): 64127-205-01
  • Packager: Laboratoires Dermo Cosmetik
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Uses

    • Helps treat acne pimples.
    • Dries and helps clear up acne pimples.
    • Helps prevent new acne pimples.
  • Warnings

    For external use only.

    Do not useif you have very sensitive skin.

    When using this product

    • Avoid contact with the eyes, lips and mouth; if contact occurs, rinse thoroughly with water.
    • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless otherwise directed by a doctor.
    • Skin reactions:This product may cause irritation, burning, itching, swelling and blistering of the skin. If any of the above noted symptoms occur, discontinue use.

    Stop use and ask a doctor if

    • The skin reaction becomes severe or spreads beyond the site of application.
    • You develop severe itching, hives, swelling of eyes or mouth, blistering or difficulty breathing.
    • No substantial improvement occurs within 6 to 8 weeks.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wash hands with a non-medicinal soap.
    • Clean the skin thoroughly with the appropriate GMC Medical cleanser before applying this product.
    • For New Users: Apply product to a small area once a day for three days to test if you are sensitive to this product.
    • Apply morning and/or evening on the affected areas, or as recommended by your doctor.
    • Start with one application daily, then increase if needed.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other information

    Store at 15-30°C (59-86°F).

  • Questions?

    USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

  • Inactive ingredients

    Ammonium Acryloyldimethyltaurate/VP Copolymer, Biosaccharide Gum-1, Butylene Glycol, Caprylyl Glycol, Carbomer, Cinnamomum Camphora (Camphor) Bark Oil, Cistus Ladaniferus Oil, Citrus Aurantium Amara (Bitter Orange) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Cymbopogon Martini Oil, Dimethicone, Ethoxydiglycol, Eugenia Caryophyllus (Clove) Leaf Oil, Glycerin, Madecassoside, Mentha Arvensis Leaf Oil, Niacinamide, Nordihydroguaiaretic Acid, Oleanolic Acid, Peg-8, Peg-40 Hydrogenated Castor Oil, Peg-60 Almond Glycerides, Pelargonium Graveolens Flower Oil, Pentylene Glycol, Peumus Boldus Leaf Extract , Salvia Officinalis (Sage) Oil, Sclerotium Gum, Sodium Hyaluronate, Triethanolamine, Tropaeolum Majus Flower/Leaf/Stem Extract, Xanthan Gum, Water/Eau.

  • SPL UNCLASSIFIED SECTION

    EXCLUSIVELY DIST. BY
    ® LABORATOIRES DERMO-COSMETIK INC.
    68 STINSON, MONTREAL, QC, CANADA H4N 2E7

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    GMC MEDICAL ®

    ACNE
    GEL

    2%
    Salicylic Acid

    Acne Treatment

    NDC 64127-205-01
    NPN 80086999

    50 ml - 1.7 fl. oz.

    PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    GMC MEDICAL ACNE 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64127-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    LABDANUM OIL (UNII: 67GS9BGA2X)  
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SAGE OIL (UNII: U27K0H1H2O)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64127-205-011 in 1 CARTON11/26/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/26/201807/31/2024
    Labeler - Laboratoires Dermo Cosmetik (249335480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Entreprises Importfab Inc.248586117manufacture(64127-205)
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