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| Product NDC Code | 64127-195 | ||||
|---|---|---|---|---|---|
| Drug Name | Gm collin puracne |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 346298 | ||||
| Application Number | M006 | ||||
| Labeler Name | Laboratoires Dermo-Cosmetik Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 2.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, AQUA/WATER/EAU, BIOSACCHARIDE GUM-1, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL, CUPRESSUS SEMPERVIRENS OIL,DIMETHICONE, ETHOXYDIGLYCOL, GLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MADECASSOSIDE, NIACINAMIDE, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, PEG-40 HYDROGENATED CASTOR OIL, PEG-60 ALMOND GLYCERIDES, PEG-8, PELARGONIUM GRAVEOLENS FLOWER OIL, PENTYLENE GLYCOL, PEUMUS BOLDUS LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SCLEROTIUM GUM, SODIUM HYALURONATE, TRIETHANOLAMINE, TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT, XANTHAN GUM.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps treat acne pimples. Dries and helps clear up acne pimples. Helps prevent new acne pimples.
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.GM COLLIN PURACNE Salicylic Acid AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER BIOSACCHARIDE GUM-1 BUTYLENE GLYCOL CAPRYLYL GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CAMPHOR OIL DIMETHICONE DIETHYLENE GLYCOL MONOETHYL ETHER GLYCERIN MADECASSOSIDE NIACINAMIDE OLEANOLIC ACID POLYETHYLENE GLYCOL 400 POLYOXYL 40 HYDROGENATED CASTOR OIL PEG-60 ALMOND GLYCERIDES PELARGONIUM GRAVEOLENS FLOWER OIL PENTYLENE GLYCOL BETASIZOFIRAN HYALURONATE SODIUM TROLAMINE XANTHAN GUM WATER SALICYLIC ACID SALICYLIC ACID PHENOXYETHANOL BIOTIN SODIUM METABISULFITE PEUMUS BOLDUS LEAF TROPAEOLUM MAJUS FLOWERING TOP ROSEMARY OIL MASOPROCOL SODIUM CITRATE CITRIC ACID MONOHYDRATE LAVENDER OIL CUPRESSUS SEMPERVIRENS LEAF OIL ETHYLHEXYLGLYCERIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton G.M. COLLIN PURACNE GEL Acne Treatment NDC 64127-195-01 NPN 80086999 50 ml - 1.7 fl. oz . PP label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Product / Drug Facts
www.gmcollin.com MADE IN CANADA DISTRIBUÉ EXCLUSIVEMENT PAR / EXCLUSIVELY DISTRIBUTED BY: ® LABORATOIRES DERMO-COSMETIK INC. 68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have very sensitive skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 15-30°C (59-86°F).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API