NDC 52489-003 Antibacterial Lotiontissue

Benzalkonium Chloride

NDC Product Code 52489-003

NDC 52489-003-01

Package Description: 35 mL in 1 BAG

NDC 52489-003-02

Package Description: 35 mL in 1 BOX

NDC 52489-003-03

Package Description: 46 mL in 1 BOX

NDC Product Information

Antibacterial Lotiontissue with NDC 52489-003 is a a human over the counter drug product labeled by Imperial Palace Commodity (shenzhen) Co., Ltd. The generic name of Antibacterial Lotiontissue 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 Lotiontissue 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: 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: 01-29-2021 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: 12-31-2022 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 Lotiontissue Product Label Images

Antibacterial Lotiontissue 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%

Purpose

Antiseptic

Use

To help reduce bacteria on the skin that potentially can cause disease.

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 contacting with eyes. In case of eye contact rinse eyes thoroughly with water.

Otc - Stop Use

Stop Use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children if swallowed,get medical help or contact a poison control center right away.

Directions

Apply to face, nose and hands. Discard after use.Children under 6 years of age should be supervised when using this product.

How To Uses

BagTear off the middle line of the bag and open the bag then take out of one sheet to use.Dispose the tissue to the trash bin after wiping.BoxOpen the box, take out of tissue as required.Dispose it to the trash bin after use.

Inactive Ingredients

Water, Glycerin, Aloe Barbadensis leaf extract.

* Please review the disclaimer below.