NDC 74751-001 Formoclean Hand Sanitizer

Product Information

Product Packages

NDC 74751-001-01

Package Description: 3.8 L in 1 BOTTLE

NDC 74751-001-05

Package Description: 19 L in 1 PAIL

NDC 74751-001-50

Package Description: 189 L in 1 DRUM

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

Product Details

Formoclean Hand Sanitizer is product labeled by Applichem, Inc.. The product's dosage form is and is administered via form.


What are Formoclean Hand Sanitizer Active Ingredients?

The following is the list of active ingredients in this product. 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ALCOHOL (UNII: 3K9958V90M) (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 code indicates a single concept unique identifier (RXCUI) is 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.

Formoclean 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:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)



Alcohol 80% 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.