NDC 78494-001 Antibacterial Wipes

Benzalkonium Chloride

NDC Product Code 78494-001

NDC 78494-001-01

Package Description: 1 CLOTH in 1 BAG

NDC Product Information

Antibacterial Wipes with NDC 78494-001 is a a human over the counter drug product labeled by Fitguard. The generic name of Antibacterial Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Fitguard

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It 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 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 .3 mg/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.

  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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: Fitguard
Labeler Code: 78494
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: 09-23-2020 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 Wipes Product Label Images

Antibacterial 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

Purpose

Antibacterial

Active Ingredient:

Benzalkonium Chloride 0.30%

Inactive Ingredients:

Water, Phenoxyethanol, DMDM Hydantoin, Polysorbate 20, Ethylparaben, Methylparaben, Fragrance, Disodium EDTA, Sodium Citrate, Cetylpyridinium Chloride

Uses:

For skin surface sanitizing to decrease bacteria.

Warnings:

For external use only.May irritate eyes.Keep out of reach of children unless under adult supervision.

Keep out of reach of children unless under adult supervision.

Directions:

Important! Do not open the top of the bag.1. Cut a 1" opening into the top center of the bag along dashed line.2. Pull out the center wipe from the bag through the 1" hole.3. Place the bag of wipes into the dispenser.4. Thread the center wipe through the hole in the top of the dispenser.

Instructions For Use:

Take single sheets as needed and apply topically to clean skin.

* Please review the disclaimer below.