NDC 79190-000 Summit Hand Sanitizer

Alcohol

  1. Labeler Index
  2. Imo Source (pty) Ltd
  3. NDC: 79190-000 Summit Hand Sanitizer

NDC Product Code 79190-000

NDC CODE: 79190-000

Proprietary Name: Summit Hand Sanitizer What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 79190 - Imo Source (pty) Ltd

NDC 79190-000-01

Package Description: 5000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Summit Hand Sanitizer with NDC 79190-000 is a a human over the counter drug product labeled by Imo Source (pty) Ltd. The generic name of Summit Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Imo Source (pty) Ltd

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.

Summit 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 .7 mL/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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • 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: Imo Source (pty) Ltd
Labeler Code: 79190
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: 06-30-2020 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.

Summit Hand Sanitizer Product Label Images

Summit 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(S)

Ethyl Alcohol 70% (V/V%)

Purpose

Antiseptic

Use[S]

  • To help minimize bacteria on the skin that could cause diseaseRecommended for repeated use

Warnings

For external use only • Flammable • Keep away from fire or flame

Do Not Use

  • On children less than 2 months of ageOn open skin wounds

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

Irritation, rash or redness develops and persists

Keep Out Of Reach Of Children

  • If swallowed, seek medical help or contact a Poison Control Center immediately

Directions

  • Apply enough product to cover all areas of hands Rub hands together briskly until dryChildren under 6 years of age require supervision when using this product

Other Information

  • Do not store above 105°FMay cause fabric discolorationMay harm plastics and wood finishes

Inactive Ingredients

Purified water USP, Glycerol, Hydroxyethylcellulose , Tocopheryl Acetate (Vitamin E), Benzalkonium Chloride, Tetrasodium EDTA, Citric Acid.

* Please review the disclaimer below.