NDC 82289-1836 Nourishing Hand Sanitizing

Benzalkonium Chloride

NDC Product Code 82289-1836

NDC 82289-1836-1

Package Description: 100 mL in 1 BOTTLE, PUMP

NDC Product Information

Nourishing Hand Sanitizing with NDC 82289-1836 is a a human over the counter drug product labeled by United States Mask Llc. The generic name of Nourishing Hand Sanitizing is benzalkonium chloride. The product's dosage form is insert, extended release and is administered via topical form.

Dosage Form: Insert, Extended Release - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where the medication is released, generally for localized effects; the extended release preparation is designed to allow for a reduction in dosing frequency.

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.

Nourishing Hand Sanitizing 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • STARCH, OAT (UNII: 904CE6697V)
  • BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • JOJOBA OIL (UNII: 724GKU717M)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)

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: United States Mask Llc
Labeler Code: 82289
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: 11-01-2021 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.

Nourishing Hand Sanitizing 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

Purpose

Benzalkonium chloride 0.13%.............................................Antiseptic

Uses

Hand sanitizing and to decrease bacteria on the skin

Warnings

• For external use only

Do Not Use In The Eyes.

• In case of eye contact, rinse eyes thoroughly 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.

• Instruct children on proper use. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

Apply small amount to hands and rub until dry. Lotion does not replace soap and water.

Other Information

Store between 15-30°C (59-86°F). Avoid Freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Starch, Behentrimonium Methosulfate, Caprylyl Glycol, Cetearyl Alcohol, Cetrimonium Chloride, Dimethicone, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Vitamin A Palmitate, Vitamin E Acetate, Water.

* Please review the disclaimer below.