NDC 75127-007 Hand Sanitizing Wipes

Benzalkonium Chloride

NDC Product Code 75127-007

NDC 75127-007-01

Package Description: 200 BAG in 1 CARTON > 10 POUCH in 1 BAG > 4 g in 1 POUCH

NDC 75127-007-02

Package Description: 6 PAIL in 1 CARTON > 240 POUCH in 1 PAIL > 4.04 g in 1 POUCH

NDC 75127-007-03

Package Description: 24 BAG in 1 CARTON > 80 POUCH in 1 BAG > 4.05 g in 1 POUCH

NDC 75127-007-04

Package Description: 4 BAG in 1 CARTON > 800 POUCH in 1 BAG > 4.05 g in 1 POUCH

NDC 75127-007-05

Package Description: 4 BAG in 1 CARTON > 1200 POUCH in 1 BAG > 4.05 g in 1 POUCH

NDC 75127-007-06

Package Description: 8 PAIL in 1 CARTON > 200 POUCH in 1 PAIL > 4.05 g in 1 POUCH

NDC 75127-007-07

Package Description: 200 BAG in 1 CARTON > 15 POUCH in 1 BAG > 4 g in 1 POUCH

NDC 75127-007-08

Package Description: 40 BAG in 1 CARTON > 50 POUCH in 1 BAG > 4.04 g in 1 POUCH

NDC 75127-007-09

Package Description: 12 PAIL in 1 CARTON > 240 POUCH in 1 PAIL > 4.04 g in 1 POUCH

NDC 75127-007-10

Package Description: 4 BAG in 1 CARTON > 1500 POUCH in 1 BAG > 4.04 g in 1 POUCH

NDC Product Information

Hand Sanitizing Wipes with NDC 75127-007 is a a human over the counter drug product labeled by Jurong Dongfa General Merchandise Co Ltd. The generic name of Hand Sanitizing Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Jurong Dongfa General Merchandise 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.

Hand Sanitizing 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 .13 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.

  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • QUATERNIUM-15 (UNII: E40U03LEM0)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Jurong Dongfa General Merchandise Co Ltd
Labeler Code: 75127
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: 10-20-2020 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.

Hand Sanitizing Wipes Product Label Images

Hand Sanitizing 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 0.13%

Purpose

Antiseptic

Use

●For hand sanitizing to decrease bacteria on the skin.

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

●Recommended for repeated use.

●Dries in seconds.

Warning

For external use only

Do not use in the eyes

Otc - Keep Out Of Reach Of Children

●Keep out of reach of children unless under adult supervision.

Directions

Remove lid.

Pull wipe from center of roll and thread through opening in lid. Do not push finger through opening.

Replace lid, pull wipe up, and then out at 45° angle. The next wipe dispenses automatically.

·Close lid to retain moisture.

Inactive Ingredients

Water, Propylene Glycol,Disodium EDTA, Chloro-methyl-isothiazolinone andMethyl-isothiazolinone, Potassium Sorbate, Quatermium-15, Aloe

Barbadensis Leaf Juice,Disodium Cocoamphodiacetate, Vitamin E AcetatePolysorbate-20, Citric Acid, Fragrance.

* Please review the disclaimer below.