NDC 80499-003 Hygiene Clean Unscented Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 80499-003

NDC 80499-003-01

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 80499-003-02

Package Description: 24 BOTTLE, PLASTIC in 1 BOX > 237 mL in 1 BOTTLE, PLASTIC (80499-003-01)

NDC Product Information

Hygiene Clean Unscented Hand Sanitizer with NDC 80499-003 is a a human over the counter drug product labeled by Usa Broom Llc. The generic name of Hygiene Clean Unscented Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Usa Broom Llc

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.

Hygiene Clean Unscented Hand Sanitizer 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 1.3 mg/mL

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.

  • UNDECETH-7 (UNII: R6B5PCO2JN)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Usa Broom Llc
Labeler Code: 80499
FDA Application Number: part333E 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: 09-30-2020 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.

Hygiene Clean Unscented Hand Sanitizer Product Label Images

Hygiene Clean Unscented Hand Sanitizer 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

Antimicrobial

Uses

- For hand sanitizing to decrease the bacteria on skin.- Recommended for repeated use.

Warnings

For external use only

When Using This Product

Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use And Ask A Doctor

If irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out Of Reach Of Children.

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

Directions

- Pump a small amount of foam into palm of hand- Rub thoroughly over all surfaces of both hands- Rub hands together briskly until dry

Inactive Ingredients:

Water, Propylene Glycol, Lauramine Oxide, Undecth-7, Disodium EDTA; Aloe Barbadensis Gel, Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

* Please review the disclaimer below.