NDC 81858-021 Hands First Tm

Benzalkonium Chloride

NDC Product Code 81858-021

NDC 81858-021-01

Package Description: 3785 mL in 1 BOTTLE

NDC 81858-021-02

Package Description: 59 mL in 1 BOTTLE

NDC 81858-021-04

Package Description: 118 mL in 1 BOTTLE

NDC 81858-021-06

Package Description: 177 mL in 1 BOTTLE

NDC 81858-021-08

Package Description: 236 mL in 1 BOTTLE

NDC 81858-021-12

Package Description: 354 mL in 1 BOTTLE

NDC 81858-021-16

Package Description: 473 mL in 1 BOTTLE

NDC 81858-021-32

Package Description: 946 mL in 1 BOTTLE

NDC 81858-021-64

Package Description: 1892 mL in 1 BOTTLE

NDC Product Information

Hands First Tm with NDC 81858-021 is a a human over the counter drug product labeled by Hands First, Llc.. The generic name of Hands First Tm is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Hands First, 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.

Hands First Tm 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.

  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • ALLANTOIN (UNII: 344S277G0Z)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SILVER (UNII: 3M4G523W1G)
  • ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Hands First, Llc.
Labeler Code: 81858
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: 05-07-2021 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.

Hands First Tm Product Label Images

Hands First Tm 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

Use

  • For handwashing to decrease bacteria on the skinFor temporary protection of minor cuts, scrapes, burns and chapped or cracked skin

Warning

  • For external use only.Keep out of the reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.Do not use in the eyes.Do not use on deep or puncture wounds, animal bites or serious burns.Extended use may increase risk of sunburn.

Stop Use And Ask A Doctor If:

  • Symptoms worsen, last for more than seven days, or new symptoms occur at any time

Direction

  • Uses as needed.Remove cap and pump foam into palm of hands.Rub foam onto hands.Allow to air dry.

Other Information

  • Save carton for full directions and warningsstore between 20 to 25oC (68 to 77oF)

Inactive Ingredients

Water, cocamidopropyl betaine , allantoin, glycolic acid, dimethicone, aloe vera leaf, lavender extract, colloidal silver, tetrasodium EDTA, phenoxyethanol, ethylhexyl glycerine.

Questions?

Call 1-800-603-0589 between 9am and 5pm (EST) Monday through Friday or visit www.handsfirst.com

* Please review the disclaimer below.