NDC 11344-951 Ethyl Alcohol

Ethyl Alcohol

NDC Product Code 11344-951

NDC 11344-951-16

Package Description: 59 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-29

Package Description: 200 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-34

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-38

Package Description: 296 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-45

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-49

Package Description: 443 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 11344-951-88

Package Description: 2000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Ethyl Alcohol with NDC 11344-951 is a a human over the counter drug product labeled by Vi-jon, Inc.. The generic name of Ethyl Alcohol is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Vi-jon, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Ethyl Alcohol 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 578 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.

  • SULISOBENZONE (UNII: 1W6L629B4K)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • .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: Vi-jon, Inc.
Labeler Code: 11344
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: 09-08-2014 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.

Ethyl Alcohol Product Label Images

Ethyl Alcohol 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 Alcohol 65%

Purpose

Antiseptic

Use

  • 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 developcondition persists for more than 72 hours

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 105⁰ Fmay discolor some fabricsharmful to wood finishes and plastics

Inactive Ingredients

Benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

Rear Label Text

*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.**Not manufactured or distributed by Johnson and Johnson, the owner and distributor of Purell Hand SanitizerMade in USA with US and foreign componentsDistributed by Vi-Jon, 8515 page Ave.  St. Louis, MO 63114

* Please review the disclaimer below.