HAND SANITIZER- ethyl alcohol gel 
Black Irish Products, 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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Ethyl Alcohol 75% v/v Purpose: Antiseptic

Keep out of eyes, ears, and mouth. In case of contact with the eyes, rinse eyes thoroughly with water.

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise with children under 6 years of age when using this product to avoid swallowing.

  • on chilren less then 2 months of age
  • on open skin wounds

if irritation or rash occurs. These may be signs of a serious condition.

If swallowed, get medical help or contact a Poison Control Center right away

Apply dime size amount to hands and

Hand sanitizer to help reuce bacteria that potentially can cause disease. For use when soap and water are not available.

Visit penta5usa.com or call toll free 1-800-511-5609

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

236 ML Bottle- NDC 80589-001-01236 ML, NDC: 80589-001-01

59 mL NDC 80589-001-02

59 mL NDC 80589-001-02

3785 mL, NDC 80589-001-03 3785 mL NDC 80589-001-03

60 mL NDC 80589-001-04

60 ML NC 80589-001-04

133 mL NDC 80589-001-05 133 mL NDC 80589-001-05

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
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
.ALPHA.,.BETA.-METHYLENE ADENOSINE 5'-DIPHOSPHATE (UNII: 0T2A5439OE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80589-001-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2021
2NDC:80589-001-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2021
3NDC:80589-001-033785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2021
4NDC:80589-001-0459 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2021
5NDC:80589-001-05133 mL in 1 POUCH; Type 0: Not a Combination Product03/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/29/2021
Labeler - Black Irish Products, LLC. (131420039)
Establishment
NameAddressID/FEIBusiness Operations
Redi-2-PaQ Home Products, LLC.081148102manufacture(80589-001)
Establishment
NameAddressID/FEIBusiness Operations
Black Irish Products131420039label(80589-001)

Revised: 3/2021
Document Id: be5d0b4e-44a1-852b-e053-2a95a90a49bb
Set id: be5d0c55-519d-4836-e053-2995a90a6edb
Version: 1
Effective Time: 20210325
 
Black Irish Products, LLC.