NDC 71734-331 Purenique Hygiene Solutions Antiseptic Wipes

Benzalkonium Chloride

NDC Product Code 71734-331

NDC CODE: 71734-331

Proprietary Name: Purenique Hygiene Solutions Antiseptic Wipes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71734 - Jiangmen Shuizirun Sanitary Articles Co., Ltd.
    • 71734-331 - Purenique Hygiene Solutions Antiseptic Wipes

NDC 71734-331-01

Package Description: 2 g in 1 POUCH

NDC Product Information

Purenique Hygiene Solutions Antiseptic Wipes with NDC 71734-331 is a a human over the counter drug product labeled by Jiangmen Shuizirun Sanitary Articles Co., Ltd.. The generic name of Purenique Hygiene Solutions Antiseptic Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Jiangmen Shuizirun Sanitary Articles Co., Ltd.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Purenique Hygiene Solutions Antiseptic 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Jiangmen Shuizirun Sanitary Articles Co., Ltd.
Labeler Code: 71734
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: 10-30-2020 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.

Purenique Hygiene Solutions Antiseptic Wipes Product Label Images

Purenique Hygiene Solutions Antiseptic 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

Benzalkonium Chloride .......... 0.13 %

Purpose

Antiseptic

Uses:

Clean and refreshes hands without soap and water.

Warnings

Warnings

Otc - Do Not Use

For external use only. Stop use and consult doctor if skin irritation develops.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Self-dries in seconds. Leave skin soft and smooth.Other information: Storage and handling: Store in cool place.

Inactive Ingredients:

Glycerol, 1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water

* Please review the disclaimer below.