NDC 50241-986 E3 Foaming Hand Sanitizer

N/a

NDC Product Code 50241-986

NDC 50241-986-02

Package Description: 4 BOTTLE, PLASTIC in 1 PACKAGE > 3756 g in 1 BOTTLE, PLASTIC (50241-986-01)

NDC Product Information

E3 Foaming Hand Sanitizer with NDC 50241-986 is a a human over the counter drug product labeled by Morgan Gallacher Inc.. The generic name of E3 Foaming Hand Sanitizer is n/a. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Morgan Gallacher Inc.

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.

E3 Foaming 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 g/100g

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)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
  • GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Morgan Gallacher Inc.
Labeler Code: 50241
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-23-2018 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.

E3 Foaming Hand Sanitizer Product Label Images

E3 Foaming 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

Active IngredientBenzalkonium Chloride 0.1 %

Uses

  • UsesFor hand sanitizing to decrease bacteria on the skinRecommended for repeated use

Purpose

PurposeAntimicrobial

Warnings

  • WarningsFor external use onlyWhen using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Do not ingest.Stop use and ask a doctor if irritation or redness develops and conditions persist.

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Conrol Center right away.

Directions

  • DirectionsPump a small amount of foam into palm of handRub thoroughly over all surfaces of both handsRub hands together briskly until dry

Inert Ingredients:

  • Inactive Ingredientswatercetrimonium chloridelaurtrimonium chloridedihydroxyethyl cocamine oxideglycereth-17 cocoatecitric acid monohydrate

E3 Foaming Hand Sanitizer

E3 Foaming Hand Sanitizer

* Please review the disclaimer below.