NDC 11084-026 Alcare Enhanced Foaming Hand Sanitizer

Alcohol

NDC Product Code 11084-026

NDC 11084-026-12

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 11084-026-27

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 11084-026-40

Package Description: 400 mL in 1 BOTTLE, PUMP

NDC Product Information

Alcare Enhanced Foaming Hand Sanitizer with NDC 11084-026 is a a human over the counter drug product labeled by Sc Johnson Professional Usa Inc.. The generic name of Alcare Enhanced Foaming Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sc Johnson Professional Usa 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.

Alcare Enhanced 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.

  • ALCOHOL 65 g/100mL

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)
  • BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
  • PROPYL ALCOHOL (UNII: 96F264O9SV)
  • BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • PEG-200 HYDROGENATED GLYCERYL PALMATE (UNII: W161T051Y1)
  • DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)

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: Sc Johnson Professional Usa Inc.
Labeler Code: 11084
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: 10-01-2019 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: 12-31-2020 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.

Alcare Enhanced Foaming Hand Sanitizer Product Label Images

Alcare Enhanced 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

Other

Drug Facts

Active Ingredient

ETHYL ALCOHOL, 72% v/v

Purpose

Antibacterial

Uses

  • For hand sanitizing to reduce bacteria on the skin

Warnings

For external use only

Flammable

Keep away from fire or flame.

When Using This Product

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

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

  • Apply foaming sanitizer to cover handsrub into skinno rinsing required

Inactive Ingredients

Aqua (Water) Behentrimonium Chloride, BIS-PEG-12 Dimethicone, Coco-Glucoside, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Glyceryl Oleate, PEG-200 Hydrogenerated Glyceryl Palmate, PEG-7 Glyceryl Cocoate, Propyl Alcohol.

* Please review the disclaimer below.