ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States

Hand Sanitizer

9432

Due to the COVID-19 pandemic, most retailers can’t keep up with the demand for hand sanitizer. FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs, provided that the following requirements are met.

FDA REGISTRATION

ITB HOLDINGS LLC has been helping companies around the world register with the FDA and list their hand sanitizers.

Hand sanitizers are over-the-counter (OTC) drug products and must therefore be manufactured based on an FDA Monograph.

■ The hand sanitizer is manufactured using only the following ingredients in the preparation of the product.

  • Alcohol (ethanol) that is not less than 94.9% ethanol by volume or United States Pharmacopeia (USP grade) Isopropyl Alcohol
  • Glycerin (glycerol) USP or Food Chemical Codex (FCC) (also known as “food grade”)
  • Hydrogen peroxide
  • Sterile water (by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.

■ The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.

■ The hand sanitizer is manufactured according to the following formula consistent with World Health Organization (WHO) recommendations.

■ The ethanol or isopropyl alcohol is used as active ingredient in the correct amount.

WHAT WE OFFER

Our fees are the lowest. See below.

LABELER CODE
NATIONAL DRUG CODE (NDC)
DRUG
ESTABLISHMENT
REGISTRATION

 

LISTING OF HAND SANITIZER

 

$350.00 SERVICE FEE

 

FDA
Establishment Identifier (FEI)
FOREIGN COMPANIES
FREE U.S. Agent Service
LABEL REVIEW
$99.00
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