NDC 52489-002 Antibacterial Wipes

Benzalkonium Chloride

NDC Product Code 52489-002

NDC 52489-002-01

Package Description: 360 mL in 1 PACKAGE

NDC 52489-002-02

Package Description: 370 mL in 1 PAIL

NDC 52489-002-03

Package Description: 940 mL in 1 PAIL

NDC 52489-002-04

Package Description: 3000 mL in 1 PAIL

NDC Product Information

Antibacterial Wipes with NDC 52489-002 is a a human over the counter drug product labeled by Imperial Palace Commodity (shenzhen) Co., Ltd. The generic name of Antibacterial Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Imperial Palace Commodity (shenzhen) Co., Ltd

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 1.3 mg/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.

  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • WATER (UNII: 059QF0KO0R)
  • CHLORPHENESIN (UNII: I670DAL4SZ)

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: Imperial Palace Commodity (shenzhen) Co., Ltd
Labeler Code: 52489
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: 05-27-2020 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.

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

Other

DRUG FACTS

Active Ingredient(S)

Benzalkonium chloride :0.13% (W/W)

Purpose

Antibacterial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Do Not Use

Do not use if you are allergic to any of the ingredients.

Otc - When Using

When using this product avoid contact with eyes. In case of eye contact,flush thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children. If swallowed, get medical help or contact a Poision Control Center right away.

Directions

Adults and children 6 years and over : Wet hands thoroughly with wipes and allow to dry, dispose of used wipe in trash, don not flushChildren under 6 years: ask a doctor before use.

How To Uses

Packs●Peel back lid and then label.●Remove wipes as required.●Replace lid and label to keep wipes moist.Buckets●Open the bucket lid from the top.●Locate tear cut in the inner pouch, tear straight to open. Do not remove wipesroll from pouch.●Pull first wipes from center of roll up through opening.●Thread first wipe through dispensing nozzle in top of roll.●Close the bucket lid and dispense the wipes as required.

Inactive Ingredients

●Water(Aqua) ●Cetylpyridinium chloride ●Chlorphenesin ●Ethylhexylglycerin ●Propylene glycol●Glycerol

* Please review the disclaimer below.