HAND SANITIZER- ethyl alcohol gel 
Black Irish Products

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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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)

Ethyl 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

Water, Carbool Aqua SF1, Hydrogen Peroxide 3%, Glycerol, Fragrance, AMP PC2000

Package Label - Principal Display Panel

946 mL NDC: 80589-001-06

946 mL NDC 80589-001-06

532 mL NDC 80589-001-07

532 mL NDC 80589-001-07

236 mL NDC 80589-001-08

236 mL NDC 80589-001-08

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80589-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
.ALPHA.,.BETA.-METHYLENE ADENOSINE 5'-DIPHOSPHATE (UNII: 0T2A5439OE)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80589-001-06946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2020
2NDC:80589-001-07532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2020
3NDC:80589-001-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/29/2020
Labeler - Black Irish Products (131420039)
Establishment
NameAddressID/FEIBusiness Operations
Redi-2-PaQ Home Products, LLC.081148102manufacture(80589-001)
Establishment
NameAddressID/FEIBusiness Operations
Black Irish Products131420039label(80589-001)

Revised: 6/2021
Document Id: c4422855-4152-f2d6-e053-2995a90a2093
Set id: c4439dc1-965d-0b8c-e053-2995a90a2457
Version: 1
Effective Time: 20210608
 
Black Irish Products