GMC MEDICAL ACNE- salicylic acid gel 
Laboratoires Dermo Cosmetik

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GMC MEDICAL ®Acne Gel

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

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

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.

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
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)

Revised: 10/2023
Document Id: 06d39c27-649f-4de5-e063-6394a90abb72
Set id: 4126e3fc-686f-4c90-bcf4-9c7f4a9f1d18
Version: 3
Effective Time: 20231003
 
Laboratoires Dermo Cosmetik