HAND SANITIZER- isopropyl alcohol gel 
Consolidated Chemicals, LLC

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.

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Hand Sanitizer Gel

Hand Sanitizer 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. An inactive ingredient (Hydroxypropyl methylcellulose) has been added to increase the viscosity of hand sanitizer.

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 and addition of hydroxypropyl Methylcellulose (inactive ingredient added to increase product viscosity):

  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.
  5. Hydroxypropyl Methylcellulose USP (0.5% w/v)

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, hydroxypropyl methyl cellulose USP, purified water USP

Package Label - Principal Display Panel

118 ml NDC: 75632-110-04 118 ml label

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75632-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (750 MPA.S) (UNII: K9U3DM12ZR) 0.5 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75632-110-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2020
Labeler - Consolidated Chemicals, LLC (117478303)
Registrant - Consolidated Chemicals, LLC (117478303)
Establishment
NameAddressID/FEIBusiness Operations
Consolidated Chemicals, LLC117478303manufacture(75632-110)

Revised: 12/2022
Document Id: f100ddb4-f8c0-2044-e053-2995a90a5666
Set id: a4c8cb73-3180-31fa-e053-2a95a90a7d4e
Version: 3
Effective Time: 20221229
 
Consolidated Chemicals, LLC