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| Product NDC Code | 72518-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Triclara |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1046442 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Nightingale Pharmaceuticals, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium Chloride (0.13%)
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 clean the affected area with soap and water and thoroughly dry the area. for best results apply a small quantity with a rubbing motion 8 times (once every 2 hours while awake) daily at onset of symptoms until cleared. wash hands after applying. do not share this product with others. retain these directions for help with use. for use on children under 12 years: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, water, N-acetyl cysteine, sodium hydroxide (for pH), ascorbic acid
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 treatment of cold sore / fever blister effective relief of symptoms of cold sore / fever blister protects against infections in sores, burns, cuts and scrapes
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic - First Aid
Spl product data elements
Usually a list of ingredients in a drug product.TriClara Benzalkonium Chloride WATER ACETYLCYSTEINE GLYCERIN SODIUM HYDROXIDE ASCORBIC ACID BENZALKONIUM CHLORIDE BENZALKONIUM
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.TriClara ® ON & GONE New Antiseptic Cold Sore Treatment 0.13% Benzalkonium Chloride FAST CLEAR EFFECTIVE BETTER APPEARANCE + SOOTHING RELIEF Cold Sore / Fever Blister Antiseptic NET WT 3.5G / .12 OZ Distributed by: Nightingale Pharmaceuticals, Inc. Santee, CA 92071 www.triclara.com RETAIN CARTON FOR COMPLETE PRODUCT INFORMAITON front label drug facts panel
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.Drug Facts
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 poison control at 1-800-222-1222.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at 15 to 25°C (59 to 77°F), in a dry place, away from heat, humidity and direct sunlight Discard 30 days after removeal from vauumed pouch.
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 consult a doctor if the condition persists or gets worse.
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 in or around eyes or ears. Consult a physician before using on puncture wounds, serious burns or animal bites. Allergy alert: Do not use if you are allergic to any ingredients in this product.
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