GMC MEDICAL ACNE- salicylic acid gel

GMC MEDICAL Acne by

Drug Labeling and Warnings

GMC MEDICAL Acne by is a Otc medication manufactured, distributed, or labeled by Laboratoires Dermo Cosmetik, Entreprises Importfab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 use if 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.

INGREDIENTS AND APPEARANCE

GMC MEDICAL ACNE 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CAMPHOR OIL (UNII: 75IZZ8Y727)
LABDANUM OIL (UNII: 67GS9BGA2X)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
ORANGE OIL (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-205-01	1 in 1 CARTON	11/26/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	11/26/2018

Labeler - Laboratoires Dermo Cosmetik (249335480)

Establishment
Name	Address	ID/FEI	Business Operations
Entreprises Importfab Inc.		248586117	MANUFACTURE(64127-205)