NDC 79390-999 Sanitize 99.9% Antiseptic Hand Sanitizer

Ethyl Alcohol

NDC Product Code 79390-999

NDC 79390-999-05

Package Description: 50 mL in 1 BOTTLE

NDC 79390-999-10

Package Description: 100 mL in 1 BOTTLE

NDC 79390-999-20

Package Description: 200 mL in 1 BOTTLE

NDC 79390-999-50

Package Description: 500 mL in 1 BOTTLE

NDC 79390-999-51

Package Description: 5000 mL in 1 CAN

NDC Product Information

Sanitize 99.9% Antiseptic Hand Sanitizer with NDC 79390-999 is a a human over the counter drug product labeled by Radico Khaitan Limited. The generic name of Sanitize 99.9% Antiseptic Hand Sanitizer is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Radico Khaitan Limited

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.

Sanitize 99.9% Antiseptic 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 80 mL/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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • 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.
  • 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: Radico Khaitan Limited
Labeler Code: 79390
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: 07-06-2020 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.

Sanitize 99.9% Antiseptic Hand Sanitizer Product Label Images

Sanitize 99.9% Antiseptic 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 alcohol 80% v/v

Purpose

Antiseptic

Uses

  • Hand sanitizer to decrease bacteria on the skinrecommended for repeated usefor use when soap and water are not available

Warnings

  • Flammable, keep away from fire/flameFor external use onlyDo not usein children less than 2 months of ageon open skin woundsWhen using this product   • do not get into eyes. In case of contact, rinse eyes thoroughly with waterStop use and ask a doctor ifirritation and redness developcondition persists for more than 72 hours

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

  • Wet hands thoroughly with product and allow to dry without wipingsupervise children under 6 yeas of age when using this product to avoid swallowing

Other Information

  • Store between 15-30°C (59-86°F)avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Glycerin, hydrogen peroxide, water

Questions?

+1-732-500-6268You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Other

80% ALCOHOL STRENGTHWHO recommended FormulationCLEAN HANDS SAVE LIVESMANUFACTURED BY: RADICO KHAITAN LTD., BAREILY ROAD, RAMPUR, U.P, INDIA-244901MADE IN INDIAEXPIRY DATE: 24 MONTHS FROM THE DATE OF MANUFACTUREexports@radico.co.inA product of India's largest spirits Distiller

* Please review the disclaimer below.