HAND SANITIZER- alcohol solution 
Gala SRL

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.

----------

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.

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
HAND SANITIZER
HAND RUB
Alcohol Antiseptic 80%

236 mL NDC: 78323-104-20

Hand Rub Sanitizer

HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78323-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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:78323-104-20236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - Gala SRL (815941453)
Registrant - Gala SRL (815941453)
Establishment
NameAddressID/FEIBusiness Operations
Gala SRL815941453manufacture(78323-104)

Revised: 10/2021
Document Id: cedec838-ac3a-5f5f-e053-2995a90a8d64
Set id: a6ce83d2-80e3-0670-e053-2995a90ab647
Version: 3
Effective Time: 20211021
 
Gala SRL