HAND SANITIZER- isopropyl alcohol liquid 
Imperial Western Products, 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 Sanitizer Non-Sterile Solution
Isopropyl Alcohol Antiseptic 75% Hand Gel

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. Isopropyl Alcohol (75%, 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)

Isopropyl Alcohol 75% 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

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

208,000 ml NDC: 77344-002-09

6x10 55 Gallon

18,900 ml NDC: 77344-002-07

6x10 5 Gallon

3784 ml NDC: 77344-002-05

5x10 1 Gallon

946 ml NDC: 77344-002-02

6x8 32oz

473 ml NDC: 77344-002-01

6x4 16oz

250 ml NDC: 77344-002-25

3.25 x 3 8oz

HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77344-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL750 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 5 mL  in 1000 mL
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH) 7 mL  in 1000 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 1000 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 1.25 mL  in 1000 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77344-002-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
2NDC:77344-002-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
3NDC:77344-002-053784 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
4NDC:77344-002-0718900 mL in 1 PAIL; Type 0: Not a Combination Product05/18/2020
5NDC:77344-002-09208000 mL in 1 DRUM; Type 0: Not a Combination Product05/18/2020
6NDC:77344-002-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - Imperial Western Products, Inc. (046592515)
Establishment
NameAddressID/FEIBusiness Operations
Imperial Western Products, Inc.046592515manufacture(77344-002)

Revised: 1/2022
Document Id: d57e9ffb-8731-4bf9-e053-2995a90a80ff
Set id: a60680ed-11b0-0098-e053-2995a90a93a3
Version: 2
Effective Time: 20220113
 
Imperial Western Products, Inc.