GMC MEDICAL  ACNE TREATING- salicylic acid gel 
Laboratoires dermo Cosmetik Inc

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.

----------

GMC Medical®
Acne Treating Gel

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Medication

Uses

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

Warnings

For external use only.

Flammable, keep away from open fire or flame.

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.
  • Because excessive drying of the skin may occur, 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

Alcohol, Ammonium Hydroxide, Benzalkonium Chloride, Butylene Glycol, C12-15 Alkyl Lactate, C13-14 Isoparaffin, Capryloyl Glycine, Cedrus Atlantica Bark Extract, Cetyl Lactate, Cinnamomum Zeylanicum Bark Extract, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cyclopentasiloxane, Dehydroxanthan Gum, Denatonium Benzoate, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Laureth-7, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Portulaca Oleracea Extract, PPG-2 Isoceteth-20 Acetate, Propylene Glycol, Sarcosine, t-Butyl Alcohol, Tetrasodium EDTA, Water/Eau.

Distributed by:
® LABORATOIRES DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QC, CANADA H4N 2E7

PRINCIPAL DISPLAY PANEL - 50 g Tube Box

GMC MEDICAL®

ACNE
TREATING GEL

2%
Salicylic Acid

Acne Treatment

NDC 64127-185-01
NPN XXXXXX

50 g - Net wt. 1.8 oz.

PRINCIPAL DISPLAY PANEL - 50 g Tube Box
GMC MEDICAL   ACNE TREATING
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64127-185
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2000 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Ammonia (UNII: 5138Q19F1X)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Butylene Glycol (UNII: 3XUS85K0RA)  
C12-15 Alkyl Lactate (UNII: GC844VRD7E)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Capryloyl Glycine (UNII: 8TY5YO42NJ)  
Cedrus Atlantica Bark (UNII: ITP1Q41UPF)  
Cetyl Lactate (UNII: A7EVH2RK4O)  
Cinnamon Bark Oil (UNII: XE54U569EC)  
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dehydroxanthan Gum (UNII: 63ZP7I1BQO)  
Denatonium Benzoate (UNII: 4YK5Z54AT2)  
Glycerin (UNII: PDC6A3C0OX)  
Witch Hazel (UNII: 101I4J0U34)  
Laureth-7 (UNII: Z95S6G8201)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polyacrylamide (1500 MW) (UNII: 5D6TC4BRWV)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Purslane (UNII: M6S840WXG5)  
PPG-2 Isoceteth-20 Acetate (UNII: BI6C7YO419)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sarcosine (UNII: Z711V88R5F)  
Tert-butyl Alcohol (UNII: MD83SFE959)  
Edetate Sodium (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64127-185-011 in 1 BOX02/06/201702/09/2018
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/01/201702/09/2018
Labeler - Laboratoires dermo Cosmetik Inc (249335480)

Revised: 12/2018
 
Laboratoires dermo Cosmetik Inc