NDC 58037-104 Antibacterial Hand

Benzalkonium Chloride

NDC Product Code 58037-104

NDC 58037-104-11

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Antibacterial Hand with NDC 58037-104 is a a human over the counter drug product labeled by Pride Products Corp.. The generic name of Antibacterial Hand is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Pride Products Corp.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Antibacterial 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 g/100mL

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)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CITRAL (UNII: T7EU0O9VPP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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: Pride Products Corp.
Labeler Code: 58037
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: 02-06-2021 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: 12-31-2022 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.

Antibacterial Hand Product Label Images

Antibacterial 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% M/M)

Purpose

ANTIMICROBIAL

Uses

SIMPLY SOFT LIQUID SOAP CLEANS HANDS WITHOUT DRYING YOUR SKIN. PERFECT FOR ALL SKIN TYPES.

Warnings

KEEP AWAY FROM DIRECT SUNLIGHT. IN CASE OF CONTACT WITH EYES, RINSE EYES WITH PLENTY OF WATER.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

WET YOUR HANDS WITH CLEAN WATER. FILL OPEN PALM WITH ONE PUMPFUL OF SIMPLY SOFT LIQUID SOAP. LATHER YOUR HANDS BY RUBBING THEM TOGETHER WITH THE SOAP. RINSE YOUR HANDS UNDER CLEAN, RUNNING WATER.

Inactive Ingredients

AQUA (WATER), LAURYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, LAURAMINE OXIDE, GLYCERIN, PEG 120 METHYL GLUCOSE DIOLEATE, CITRIC ACID, PARFUM, TETRASODIUM EDTA, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, LIMONENE, CITRAL, FD&C YELLOW NO. 6, D&C RED NO. 33.

* Please review the disclaimer below.