NDC 65321-039 Enriched Foam Alcohol-free Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 65321-039

NDC 65321-039-01

Package Description: 4 POUCH in 1 BOX > 1100 mL in 1 POUCH

NDC 65321-039-02

Package Description: 4 POUCH in 1 BOX > 1300 mL in 1 POUCH

NDC 65321-039-03

Package Description: 6 POUCH in 1 BOX > 800 mL in 1 POUCH

NDC Product Information

Enriched Foam Alcohol-free Hand Sanitizer with NDC 65321-039 is a a human over the counter drug product labeled by Rubbermaid Commercial Products Llc. The generic name of Enriched Foam Alcohol-free Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1020365.

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.

Enriched Foam Alcohol-free 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.


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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DECYLAMINE OXIDE (UNII: G387VUT5EZ)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

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: Rubbermaid Commercial Products Llc
Labeler Code: 65321
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: 06-21-2021 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".

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Enriched Foam Alcohol-free Hand Sanitizer Product Label Images

Enriched Foam Alcohol-free 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

Other

Drug Facts

Distributed by | Rubbermaid Commercial Products LLC 3124 Valley Avenue, Winchester, VA U.S.A. 22601-2694

Active Ingredient

0.13% Benzalkonium Chloride

Purpose

Antiseptic Cleaner

Use

To decrease potentially harmful germs on skin.

Warnings

  • For external use only.

Otc - When Using

  • When using this product avoid contact with eyes. In case of eye contact, flush with water.

Otc - Stop Use

  • Stop use and ask a doctor, if irritation or redness persist.

Otc - Do Not Use

  • Do not ingest.

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

Place hands under the dispenser, allow 0.4 mL of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry

Inactive Ingredients

Water (Aqua), Propylene Glycol, PEG-6 Caprylic/Capric Glycerides, Phenoxyethanol, Decylamine Oxide, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Lactic Acid, Shea Butteramidopropyl Betaine, Sodium Chloride, Hexylene Glycol, Benzoic Acid, Tocopherol, Sodium Citrate

Questions?

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