NDC 71611-080 Benzalkonium Chloride Modess Basics

Antibacterial Wash

NDC Product Code 71611-080

NDC 71611-080-35

Package Description: 354 mL in 1 BOTTLE, SPRAY

NDC Product Information

Benzalkonium Chloride Modess Basics with NDC 71611-080 is a a human over the counter drug product labeled by Click Products Llc. The generic name of Benzalkonium Chloride Modess Basics is antibacterial wash. The product's dosage form is liquid and is administered via topical form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Benzalkonium Chloride Modess Basics 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.

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)
  • ALLANTOIN (UNII: 344S277G0Z)

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: Click Products Llc
Labeler Code: 71611
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: 08-25-2021 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.

Benzalkonium Chloride Modess Basics Product Label Images

Benzalkonium Chloride Modess Basics 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

Otc - Active Ingredient

Benzalkonium Chloride - 0.13%

Otc - Purpose

Purpose - Antibacterial

Indications & Usage

For incontinent care wash to quickly emulsify body waste even in the most sensitive perineal areas. Enriched with Aloe to help soothe and promote healing of fragile irritated skin. pH balance and helps eliminate odor


Warning - For external use only

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Otc - Stop Use

  • Stop use and ask a doctor ifirritaion or redness developscondition 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

Dosage & Administration

Spray wash where urine, feces or emesis has soiled skin, pad, linens, and clothing. Remove bulk of feces or emesis. Spray additional wash on a warm wet cloth.cleanse the skin of all remaining residueNote: If the area needing care is sizable and fecal or emesis material massive- rinsing is advised.add one capful to the regular laundry to eliminate residual odors.

Inactive Ingredient

Water, Sodium Laureth Sulfate, Cocamidopropyl betaine, aloe vera leaf, Vit E, Vit D, Vit A, Allantoin, Citric acid, Methylchloroisothiazolinone and Methylisothiazolinone

* Please review the disclaimer below.