NDC 44577-711 Tri-soft Softening

Benzalkonium Chloride

NDC Product Code 44577-711

NDC 44577-711-08

Package Description: 236.59 mL in 1 BOTTLE

NDC Product Information

Tri-soft Softening with NDC 44577-711 is a a human over the counter drug product labeled by Clinical Therapeutic Solutions. The generic name of Tri-soft Softening is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Clinical Therapeutic Solutions

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Tri-soft Softening 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 1.3 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PHENYLMERCURIC NITRATE (UNII: CG8692ZN14)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ALCOHOL (UNII: 3K9958V90M)

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.
  • 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: Clinical Therapeutic Solutions
Labeler Code: 44577
FDA Application Number: part333E 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: 12-06-2012 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.

Tri-soft Softening Product Label Images

Tri-soft Softening 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

Active Ingredient

BENZALKONIUM CHLORIDE (0.13 %)

Purpose

Antiseptic

Uses:

For antiseptic cleansing that will decrease bacteria on the skin without soap and water.

Warnings

For external use only.Do not use in the eyes. If eye contact occurs, rinse thoroughly with water.Stop use and consult a physician if irritation or redness develops and persists for more than 72 hours.Do not bandage tightly.If pregnant or breast feeding, contact physician prior to use.

Keep Out Of Reach Of Children

If swallowed, consult physician or poison control immediately

Directions

Mix 1 part Tri-Soft Concentrate with water q. s. to 16 parts. Saturate cotton and place over hyperkeratotic tissues for 3 minutes before reduction or debridement.

Other Ingredients

Aqua (Deionized Water), Benzyl Alcohol, Phenylmercuric Nitrate, Polysorbate-20, SD-Alcohol 40B.

Other

Tri-Soft Softening Solution is a rapid-acting emulsifying agent combined with antiseptic properties.It is specifically formulated for use on the skin prior to instrument reduction of hyperkeratotic lesions.

* Please review the disclaimer below.