HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Black Irish Products, LLC., Redi-2-PaQ Home Products, LLC., Black Irish Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 75% v/v Purpose: Antiseptic

INDICATIONS & USAGE

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.

WARNINGS

• 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

DOSAGE & ADMINISTRATION

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.

QUESTIONS

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

OTHER SAFETY INFORMATION

• Store between 15-30 Degrees C (59-86 F)
• Avoid freexing and excessive heat about 40 C (104 F)

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

236 ML, NDC: 80589-001-01

PRINCIPAL DISPLAY PANEL

59 mL NDC: 80589-001-02

PRINCIPAL DISPLAY PANEL

3785 mL, NDC: 80589-001-03

PRINCIPAL DISPLAY PANEL

60 mL NDC: 80589-001-04

PRINCIPAL DISPLAY PANEL

133 mL NDC: 80589-001-05

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80589-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80589-001-01	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/29/2021
2	NDC: 80589-001-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021
3	NDC: 80589-001-03	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/29/2021
4	NDC: 80589-001-04	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021
5	NDC: 80589-001-05	133 mL in 1 POUCH; Type 0: Not a Combination Product	03/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/29/2021

Labeler - Black Irish Products, LLC. (131420039)

Establishment
Name	Address	ID/FEI	Business Operations
Redi-2-PaQ Home Products, LLC.		081148102	manufacture(80589-001)

Establishment
Name	Address	ID/FEI	Business Operations
Black Irish Products		131420039	label(80589-001)