NDC 37012-439 Hand Sanitizer

Ethyl Alcohl

NDC Product Code 37012-439

NDC 37012-439-34

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC Product Information

Hand Sanitizer with NDC 37012-439 is a a human over the counter drug product labeled by Shopko Stores Operating Co., Llc. The generic name of Hand Sanitizer is ethyl alcohl. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Shopko Stores Operating Co., Llc

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.

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 616 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Shopko Stores Operating Co., Llc
Labeler Code: 37012
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: 01-02-2013 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 - 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.

Hand Sanitizer Product Label Images

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

Ethyl alchol 70%

Purpose

Antiseptic

Uses

  • To decrease bacteria on the skin that could cause diseaserecommended for repeated use

Warnings

For external use only-handsFlammable.  Keep away from heat and flame.

When Using This Product

  • Keep out of eyes.   In case of contact with eyes, flush thoroughly with wateravoid contact with broken skindo not inhale or ingest

Stop Use And Ask A Doctor

If skin irritation develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet hands thoroughly with product and allow to dry without wipingfor children under 6, use only under adult supervisionnot recommended for infants

Other Information

  • Do not store above 105⁰Fmay discolor some fabricsharmful to wood finishes and plastics

Inactive Ingredients

Water, aloe barbadensis leaf juice, glyceryl caprylate/caprate, isopropyl myristate, tocopheryl acetate, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance benzophenone-4, blue 1, yellow 5

Questions?

Call 1-888-593-0593

Other

*Effective at eliminating more than 99.99% of many common harmful gers and bacteria in as little as 15 seconds.Made in the USA with US and foreign componentsManufactured by Vi-Jon, Inc8515 Page Ave., St. Louis MO 63114for Shopko Stores Operating Co., LLCwww.shopko.com

* Please review the disclaimer below.