NDC 90024-001 Antiseptic Hand Wipe

Alcohol, Benzalkonium Chloride

NDC Product Code 90024-001

NDC 90024-001-01

Package Description: 6.5 g in 1 PACKAGE

NDC Product Information

Antiseptic Hand Wipe with NDC 90024-001 is a a human over the counter drug product labeled by Metro Medical Equipment Mfg. Inc. The generic name of Antiseptic Hand Wipe is alcohol, benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Metro Medical Equipment Mfg. Inc

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.

Antiseptic Hand Wipe 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/100g
  • ALCOHOL 15 g/100g

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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

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: Metro Medical Equipment Mfg. Inc
Labeler Code: 90024
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: 08-27-2020 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.

Antiseptic Hand Wipe 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

Dosage & Administration

Remove and unfold wipe from package Wipe hands and nails thoroughly Allow sking to dry without wiping Discard Properly Single Use Only

Otc - Active Ingredient

Ethyl Alcohol 15%Benzalkonium Chloride .1%

Indications & Usage

Hand sanitizer to help reduce bacteria on the skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Antiseptic

Intended Use Of The Device

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable Keep away from fire or flame For external use only When using this product aboid use near eyesIf contact occurs, rinse thoroughly with water Stop use and ask a doctor if irritation or rash appears and lastsKeep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away

Directions

Remove and unfold wipe from packageWipe hands and nails thoroughly Allow skin to dry without wipingDiscard properly Single Use Only

Other

Store at room temperature

Inactive Ingredient

Propylene glycol Phenoxyethanol Cetylpyridinium Chloride Water spunlace non-woven fabric

* Please review the disclaimer below.