NDC 63039-1007 Total Performance Antibacterial Foam Hand

Benzalkonium Chloride

NDC Product Code 63039-1007

NDC 63039-1007-2

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 3.80564 kg in 1 BOTTLE, PLASTIC (63039-1007-1)

NDC Product Information

Total Performance Antibacterial Foam Hand with NDC 63039-1007 is a a human over the counter drug product labeled by Chemco. The generic name of Total Performance Antibacterial Foam Hand is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Chemco

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.

Total Performance Antibacterial Foam Hand 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 kg/100kg

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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
  • BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

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: Chemco
Labeler Code: 63039
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-31-2020 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: 12-31-2021 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.

Total Performance Antibacterial Foam Hand Product Label Images

Total Performance Antibacterial Foam Hand 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 hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When Using This Product

Avoid contact with the eyes.In case of eye contact, flush eyes with water. Do not ingest.Stop use and contact a doctor if irritation or redness developsor if condition persist.

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical helpor contact a Poison Control Center immediately.

Directions

-Apply to wet hands, work into a lather and rinse thoroughly.-Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Caprylyl Glucoside, Glycerine, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Fragrance, Citric Acid, Aloe Vera, Yellow #5, Red #40

Antibacterial Foam Hand Soap

Total Performance Antibacterial Foam Hand Soap

* Please review the disclaimer below.