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Hygienex Hand Sanitizer

Medically reviewed by Drugs.com. Last updated on Aug 11, 2020.

Dosage form: solution
Ingredients: ALCOHOL 166.4L in 208L
Labeler: Global Impact Innovation LLC
NDC Code: 74588-570

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:

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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.

*Fermentation Alcohol

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

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.

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.

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

Package Label - Principal Display Panel

3.78 L NDC: 74588-570-04

208 L NDC: 74588-570-01

1040 L NDC: 74588-570-02

1248 L NDC: 74588-570-03

18.927 L NDC: 74588-570-05

26497.88 L NDC: 74588-570-07

32 Oz NDC: 74588-570-12

64 Oz NDC: 74588-570-13

HYGIENEX HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74588-570
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL166.4 L  in 208 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROGEN PEROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:74588-570-01208 L in 1 DRUM
2NDC:74588-570-021040 L in 1 TANK
3NDC:74588-570-031240 L in 1 TANK
4NDC:74588-570-043.785 L in 1 BOTTLE
5NDC:74588-570-0518.927 L in 1 DRUM
6NDC:74588-570-0726497.88 L in 1 CONTAINER
7NDC:74588-570-120.946 L in 1 BOTTLE
8NDC:74588-570-131.89 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Global Impact Innovation LLC (117465830)

 
Global Impact Innovation LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.