Gm Collin Puracne Gel
FDA Label NDC 64127-195

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Dermo-cosmetik Inc. for the product Gm Collin Puracne (NDC 64127-195). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Product / Drug Facts

PARABEN-FREE

EXCLUSIVELY DISTRIBUTED BY
® LABORATOIRES DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QUEBEC 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 G.M. Collin 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 skin care professional.
  • 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).

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.

Questions?

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

Principal Display Panel - 50 Ml Tube Carton

PARIS

G.M. COLLIN®

PURACNE
GEL

Acne Treatment

NDC 64127-195-01
NPN 80086999

50 ml - 1.7 fl. oz.

Principal Display Panel (50 ml Tube Carton)

Principal Display Panel (50 ml Tube Carton)

* Please review the disclaimer below.