NDC 86937-005 Fresh N Soft Antibacterial Wet Wipes

Benzalkonium Chloride

NDC Product Code 86937-005

NDC 86937-005-01

Package Description: 15 PACKAGE in 1 PACKET > 2.688 g in 1 PACKAGE

NDC 86937-005-02

Package Description: 60 PACKAGE in 1 PACKET > 3.192 g in 1 PACKAGE

NDC 86937-005-03

Package Description: 80 PACKAGE in 1 CANISTER > 2.9792 g in 1 PACKAGE

NDC Product Information

Fresh N Soft Antibacterial Wet Wipes with NDC 86937-005 is a a human over the counter drug product labeled by Kardesler Ucan Yaglar Sanayi Anonim Sirketi. The generic name of Fresh N Soft Antibacterial Wet Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Kardesler Ucan Yaglar Sanayi Anonim Sirketi

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.

Fresh N Soft Antibacterial Wet 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 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)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Kardesler Ucan Yaglar Sanayi Anonim Sirketi
Labeler Code: 86937
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: 12-23-2020 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.

Fresh N Soft Antibacterial Wet Wipes Product Label Images

Fresh N Soft Antibacterial Wet 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 Ingredients

Benzalkonium Chloride (0.1%)

Purpose

Antiseptic

Use

Decreases bacteria on the skin that could cause disease

Warnings

For external use only.• Do not use as baby wipe.• Do not use if you are allergic to any of the ingredients.• Do not use on open skin wounds.When using this products• Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.• Stop use and ask a doctor if irritation or allergic reaction occurs.

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

• Gently open resealable label, remove and use wipes as required. Keep label closed to prevent moisture loss.• No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. • Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

• Store in dry and cool place.• Production date, expiry date and lot number are printed on the pack.

Inactive Ingredients

Water, phenoxyethanol, propylene glycol, parfum, cocamidopropyl betaine, peg-40 hydrogenated castor oil, benzoic acid, tetrasodium edta, dehydroacetic acid, sodium hydroxide

* Please review the disclaimer below.