ALCOHOL HAND SANITIZER- alcohol hand sanitizer liquid 
Jarman's MIdwest Cleaning Systems Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Hand Sanitizers

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.

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.

Do not use

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.

Warnings

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

Other information

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

mcs alcohol hs quart boxmcs alcohol hs quartmcs alcohol hs 55mcs alcohol hs 4 1mcs alcohol hs 1

ALCOHOL HAND SANITIZER 
alcohol hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74663-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74663-001-044 in 1 BOX04/27/2020
13.785 L in 1 DRUM; Type 0: Not a Combination Product
2NDC:74663-001-55208 L in 1 DRUM; Type 0: Not a Combination Product04/29/2020
3NDC:74663-001-1212 in 1 BOX05/01/2020
30.946 L in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
Labeler - Jarman's MIdwest Cleaning Systems Inc (081319480)
Registrant - Jarman's MIdwest Cleaning Systems Inc (081319480)
Establishment
NameAddressID/FEIBusiness Operations
Jarman’s Midwest Cleaning Systems, Inc081319480manufacture(74663-001)

Revised: 12/2020
Document Id: b7b13115-67ce-0276-e053-2995a90acd39
Set id: a4457493-b97e-2386-e053-2995a90ad504
Version: 3
Effective Time: 20201231
 
Jarman's MIdwest Cleaning Systems Inc