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Sanigenix Liquid Hand Sanitizer

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

Dosage form: liquid
Ingredients: ALCOHOL 80mL in 100mL
Labeler: CBIO Brand Distribution International Inc.
NDC Code: 78044-300

80% Liquid Hand Sanitizer

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. Hydrogen peroxide (0.125% v/v).
  3. 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)

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on skin.

Warnings

For external use only. Flammable, keep away from source of heat & fire.

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use & ask doctor if irritation or rash occurs or redness develops & persists.

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Directions

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Inactive ingredients

Water (Aqua, Eau), Hydrogen Peroxide

Package Label - Principal Display Panel

1 GALLON (3.785L) NDC: 78044-300-04

55 GALLON (208.198L) NDC: 78044-300-05

265 GALLON (1003.13L) NDC: 78044-300-06

SANIGENIX LIQUID HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78044-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE0.125 mL  in 100 mL
WATER 
Packaging
#Item CodePackage Description
1NDC:78044-300-05208198 mL in 1 DRUM
2NDC:78044-300-043785 mL in 1 BOTTLE
3NDC:78044-300-061003130 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - CBIO Brand Distribution International Inc. (117495482)
Registrant - CBIO Brand Distribution International Inc. (117495482)

 
CBIO Brand Distribution International Inc.

Further information

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