NDC 80310-036 Wipes Solutions Antibacterial Wet Wipes

Benzalkonium Chloride

NDC Product Code 80310-036

NDC CODE: 80310-036

Proprietary Name: Wipes Solutions Antibacterial Wet 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

  • 80310 - Supplyclean Industria De Produtos De Higiene S/a

NDC 80310-036-18

Package Description: 150 PACKAGE in 1 PAIL > .0044 mL in 1 PACKAGE

NDC 80310-036-36

Package Description: 35 PACKAGE in 1 TUBE > .00685 mL in 1 PACKAGE

NDC Product Information

Wipes Solutions Antibacterial Wet Wipes with NDC 80310-036 is a a human over the counter drug product labeled by Supplyclean Industria De Produtos De Higiene S/a. The generic name of Wipes Solutions Antibacterial Wet Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Supplyclean Industria De Produtos De Higiene S/a

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.

Wipes Solutions 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 .12 g/100mL

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.

  • 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: Supplyclean Industria De Produtos De Higiene S/a
Labeler Code: 80310
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: 08-27-2020 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.

Wipes Solutions Antibacterial Wet Wipes Product Label Images

Wipes Solutions 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 Ingredient

Benzalkonium chloride 0.12% w/v

Purpose

Antibacterial

Uses

• hand wipes to decrease bacteria on the skin• recommended for repeated use• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flameFor external use onlyDo not use• in children less than 2 months of age• on open skin woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water• do not ingestStop use and ask a doctor if• irritation and redness develop• condition persists for more than 72 hours

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

• remove the plastic cover and pull the tip of the first wipe in the center of the roll• insert the tip of the scarf into the center opening of the cover from the bottom up• replace the cap, pull the first wipe and the rest will come off automatically• wipe hands thoroughly with product and allow to dry without wiping• dispose of the wipe in the trash• supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store between 15-30°C (59-86°F)• avoid freezing and excessive heat above (104°F)

Inactive Ingredient

Inactive ingredients fragrance, propylene glycol

Otc - Questions

Questions? +1-844-805-8838You may also report serious side effects to this phone number. Mon-Fri 9:00 AM-5:00 PM

* Please review the disclaimer below.