NDC 55316-952 Moisturizing Antibacterial

Benzalkonium Chloride 0.13%

NDC Product Code 55316-952

NDC 55316-952-68

Package Description: 1656 mL in 1 BOTTLE, PLASTIC

NDC 55316-952-96

Package Description: 221 mL in 1 BOTTLE, PUMP

NDC Product Information

Moisturizing Antibacterial with NDC 55316-952 is a a human over the counter drug product labeled by Dza Brands. The generic name of Moisturizing Antibacterial is benzalkonium chloride 0.13%. The product's dosage form is soap and is administered via topical form.

Labeler Name: Dza Brands

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.

Moisturizing Antibacterial 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 g/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)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • 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: Dza Brands
Labeler Code: 55316
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: 02-06-2015 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.

Moisturizing Antibacterial Product Label Images

Moisturizing Antibacterial 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

Antibacterial

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only:hands only

When Using This Product

Avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water

Stop Use And Ask A Doctor If

  • Irritation or redness developscondition persists for more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet handsapply palmful to handsscrub thoroughlyrinse thoroughly

Inactive Ingredients

Water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, myristamidopropylamine oxide, sodium chloride, PEG-120 methyl glucose dioleate, fragrance, citric acid, tetrasodium EDTA, sodium sulfate, methylchloroisothiazolinone, methylisothiazolinone, red 40, yellow 5, red 33

Questions?

1-866-322-2439

Other

This product is not manufactured or distributed by Colgate-Palmolive Company, distributor of Softsoap Crisp Clean Antibacterial Hand Soap with Moisturizers.*DISTRIBUTED BY: DZA BRANDS, LLC2110 Executive DriveSalisbury, NC 28147For product questions or concernscontact us at 1-866-322-2439Please include UPC number and code from package.

* Please review the disclaimer below.