NDC 76772-008 Antibacterial Wet Wipes

Benzalkonium Chloride

NDC Product Code 76772-008

NDC CODE: 76772-008

Proprietary Name: Antibacterial Wet Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 76772 - Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi

NDC 76772-008-40

Package Description: 40 SWAB in 1 PACKAGE

NDC Product Information

Antibacterial Wet Wipes with NDC 76772-008 is a a human over the counter drug product labeled by Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi. The generic name of Antibacterial Wet Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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 Wet Wipes 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 g/1

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • 2-METHYL-1,2-BENZOISOTHIAZOLIN-3-ONE (UNII: 81PV9X5Y68)
  • PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • WATER (UNII: 059QF0KO0R)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)

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: Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi
Labeler Code: 76772
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: 05-07-2020 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.

Antibacterial Wet Wipes Product Label Images

Antibacterial Wet Wipes 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 0.1%...........Antiseptic

Purpose

Antibacterial

Use

Decreases bacteria on skin

Warnings

For external use only.

Keep Out Of Reach Of Children

If swallowedget medical help or contact a Poison Control Center right away.

Do Not Use

If you are allergic to any of the ingredients.

When Using This Product

Do not get into eyes.If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor

If irritation or rashdevelops and continues 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

For adults and children of 2 years and over useon hands and face to clean and refresh, allowskin to air dry.For children under 2 years ask a doctor before use.

Inactive Ingredient

Water, propylene glycol,cocamidopropyl betaine, poly(hexamethyleneguanidine),PEG-7 glyceryl cocoate ,hydrochloride, glycine, tetrasodium EDTA,
 tocopheryl acetate, citric acid,fragrance, methylchloroisothiazolinone, methylisothiazolinone,PEG-40 hydrogenated castor oil.

* Please review the disclaimer below.