NDC 75816-275 Gel Hand Sanitizer

Product Information

Gel Hand Sanitizer is product labeled by Classic Coatings Systems. The product's dosage form is and is administered via form.

Product Code75816-275
Proprietary Name 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.
Gel Hand Sanitizer
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Classic Coatings Systems
Labeler Code75816
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-20-2020
Listing Expiration Date 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.
12-31-2021
Exclude Flag 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".
I
NDC Code Structure

What are the uses for Gel Hand Sanitizer?


Product Packages

NDC 75816-275-01

Package Description: 3785 mL in 1 JUG

NDC 75816-275-05

Package Description: 18927 mL in 1 PAIL

NDC 75816-275-06

Package Description: 177 mL in 1 BOTTLE, DISPENSING

NDC 75816-275-27

Package Description: 1040988 mL in 1 CONTAINER

NDC 75816-275-32

Package Description: 946 mL in 1 BOTTLE, DISPENSING

NDC 75816-275-55

Package Description: 208198 mL in 1 DRUM

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Gel Hand Sanitizer Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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)

* Please review the disclaimer below.

Gel Hand Sanitizer Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.
  • The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.


Active Ingredient(S)



Isopropyl Alcohol 75% v/v. Purpose: Antiseptic


Purpose



Antiseptic, Hand Sanitizer


Use



Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.


Warnings



For external use only. Flammable. Keep away from heat or flame


Do Not Use



  • in children less than 2 months of age
  • on open skin wounds

Otc - When Using



When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Otc - Stop Use



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


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



  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information



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

Inactive Ingredients



glycerin, hydrogen peroxide, purified water USP


* Please review the disclaimer below.