Triclara
Benzalkonium Chloride
Nightingale Pharmaceuticals, Inc.
Human Otc Drug
NDC 72518-001Triclara also known as Benzalkonium Chloride is a human otc drug labeled by 'Nightingale Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Triclara is 72518-001. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Triclara drug includes Benzalkonium Chloride - .13 g/100g . The currest status of Triclara drug is Active.
Drug Information:
| Drug NDC: | 72518-001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Triclara |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nightingale Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | BENZALKONIUM CHLORIDE - .13 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 14 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Nightingale Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046442
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | F5UM2KM3W7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 72518-001-00 | 3.5 g in 1 BOTTLE (72518-001-00) | 14 May, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic - first aid
Product Elements:
Triclara benzalkonium chloride glycerin water acetylcysteine sodium hydroxide ascorbic acid benzalkonium chloride benzalkonium
Indications and Usage:
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
Warnings:
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.
Dosage and Administration:
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.
Stop Use:
Stop use and consult a doctor if the condition persists or gets worse.
Package Label Principal Display Panel:
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