NDC 81635-001 Eenk Sanitizer Wipes

Benzalkonium Chloride

NDC Product Code 81635-001

NDC 81635-001-01

Package Description: 10 APPLICATOR in 1 PACKET > 3.5 mL in 1 APPLICATOR

NDC 81635-001-02

Package Description: 20 APPLICATOR in 1 PACKET > 3.5 mL in 1 APPLICATOR

NDC 81635-001-03

Package Description: 50 APPLICATOR in 1 PACKET > 3.5 mL in 1 APPLICATOR

NDC 81635-001-04

Package Description: 60 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC 81635-001-05

Package Description: 80 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC 81635-001-06

Package Description: 100 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC 81635-001-07

Package Description: 160 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC 81635-001-08

Package Description: 300 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC 81635-001-09

Package Description: 500 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC 81635-001-10

Package Description: 800 APPLICATOR in 1 CANISTER > 3.5 mL in 1 APPLICATOR

NDC Product Information

Eenk Sanitizer Wipes with NDC 81635-001 is a a human over the counter drug product labeled by Cleaniz Group Llc. The generic name of Eenk Sanitizer Wipes is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Cleaniz Group Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Eenk Sanitizer 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/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)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cleaniz Group Llc
Labeler Code: 81635
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: 03-12-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Eenk Sanitizer Wipes Product Label Images

Eenk Sanitizer 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

■ To decrease bacteria on the skin that could cause disease

Warnings

For external use onlyDo not useIn children less than two monthsof age.On open skin woundsWhen using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

Open package, pull wipe. Close package to retain moisture. Wet hands thoroughly with product. Allow to dry without rinsingSupervise children under six years of age when using this product to avoid swallowing

Other Information

Keep container tightly closed in a dry, cool, and well ventilated place.Recommended storage temperature: 32F to 104F (0C to 40C)

Inactive Ingredients

Alow Barbadensis leaf jiuce, Phenoxyethanol, Polysorbate 20, Propylene glycol, Tocopheryl Acetate, Water

* Please review the disclaimer below.