FDA Label for Gmc Medical Acne

View Indications, Usage & Precautions

Gmc Medical Acne Product Label

The following document was submitted to the FDA by the labeler of this product Laboratoires Dermo Cosmetik. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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.


Otc - Do Not Use



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.

Otc - Keep Out Of Reach Of Children



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.


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.


* Please review the disclaimer below.