NDC 72518-001 Triclara

Benzalkonium Chloride

NDC Product Code 72518-001

NDC 72518-001-00

Package Description: 3.5 g in 1 BOTTLE

NDC Product Information

Triclara with NDC 72518-001 is a a human over the counter drug product labeled by Nightingale Pharmaceuticals, Inc.. The generic name of Triclara is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Nightingale Pharmaceuticals, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Triclara Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE .13 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nightingale Pharmaceuticals, Inc.
Labeler Code: 72518
FDA Application Number: part333A What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-14-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Triclara Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredient Benzalkonium Chloride (0.13%)

Otc - Purpose

PurposeAntiseptic - First Aid

Indications & Usage

  • Usestreatment of cold sore / fever blistereffective relief of symptoms of cold sore / fever blisterprotects against infections in sores, burns, cuts and scrapes

Warnings

  • WarningsFor 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.

Otc - Stop Use

Stop use and consult a doctor if the condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact poison control at 1-800-222-1222.

Dosage & Administration

  • Directionsclean 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.

Other Safety Information

  • Other informationStore at 15 to 25°C (59 to 77°F), in a dry place, away from heat, humidity and direct sunlightDiscard 30 days after removeal from vauumed pouch.

Inactive Ingredient

Inactive ingredientsglycerin, water, N-acetyl cysteine, sodium hydroxide (for pH), ascorbic acid

* Please review the disclaimer below.