NDC 75109-511 Zogics Antibacterial Wipes

Benzalkonium Chloride

NDC Product Code 75109-511

NDC 75109-511-01

Package Description: 4 PACKAGE in 1 CARTON > 2000 NOT APPLICABLE in 1 PACKAGE > 3234 g in 1 NOT APPLICABLE

NDC 75109-511-02

Package Description: 12 CANISTER in 1 CARTON > 150 NOT APPLICABLE in 1 CANISTER > 420 g in 1 NOT APPLICABLE

NDC 75109-511-03

Package Description: 24 PACKAGE in 1 CARTON > 50 NOT APPLICABLE in 1 PACKAGE > 270 g in 1 NOT APPLICABLE

NDC 75109-511-04

Package Description: 16 PACKAGE in 1 CARTON > 80 NOT APPLICABLE in 1 PACKAGE > 430 g in 1 NOT APPLICABLE

NDC Product Information

Zogics Antibacterial Wipes with NDC 75109-511 is a a human over the counter drug product labeled by Kangna (zhejiang) Medical Supplies Co., Ltd.. The generic name of Zogics Antibacterial Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Kangna (zhejiang) Medical Supplies 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.

Zogics 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 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.

  • WATER (UNII: 059QF0KO0R)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • 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: Kangna (zhejiang) Medical Supplies Co., Ltd.
Labeler Code: 75109
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: 07-07-2020 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.

Zogics Antibacterial Wipes Product Label Images

Zogics 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

Active Ingredient

Benzalkonium Chloride 0.3%

Purpose

Antiseptic

Use

●For hand sanitizing to decrease bacteria on the skin.

●Apply topically to the skin to help prevent cross contamination.

●Not Recommended for repeated use.

●Dries in seconds.

Warning

Warnings■flammable, keep away from fire and flame■do not use in

or around the eyes■stop use and ask a doctor if too much skin irritation

develops or sensitivity develops or increases■keep out of reach of

children. If swallowed, contact medical help or call Poison Control

immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, contact medical help or call Poison Control immediately.

Directions

●Open top of bag by tearing at notch across to access

resealable zipper.

●Pull zipper apart to create a 2”opening at center.

●Place bag of wet wipes upright into the dispenser.

●Pull wipes from center and guide accordingly through

the dispensing hole.

●Simply wipe surface to be disinfected and allow

surface to air dry 4 minutes before use.

Other information

●Lot No. Manufacture date and Expiration date can be

found on package.

Inactive Ingredients

Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben,

Methylparaben, Polysorbate 20, Fragrance, Disodium

EDTA, Sodium Citrate, Cetylpyridinium Chloride.

* Please review the disclaimer below.