HAND SANITIZER- alcohol solution

hand sanitizer by

Drug Labeling and Warnings

hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Pernod Ricard USA, Firestone and Robertson Distillery, Rabbit Hole Spirits, Smooth Ambler Spirits. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient[s] Purpose

Alcohol 80% v/v ................................. Anitseptic

WARNINGS

Warnings:

For External use only. Flammable. Keep away from heat and flame

DO NOT USE

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mounth. In case of contact with eyes flush thoroughly with water.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE

Directions

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

OTHER SAFETY INFORMATION

Other information:

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

INDICATIONS & USAGE

Use[s)

Hand Sanitizer to help reduce bacteria that potentially can cause disiease. For use when soap and water are not available.

DOSAGE & ADMINISTRATION

Directions

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

PURPOSE

Use[s)

Hand Sanitizer to help reduce bacteria that potentially can cause disiease. For use when soap and water are not available.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73785-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	8 mL  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73785-001-01	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/20/2020
2	NDC: 73785-001-02	189271 mL in 1 DRUM; Type 0: Not a Combination Product	03/20/2020
3	NDC: 73785-001-03	245000 mL in 1 DRUM; Type 0: Not a Combination Product	03/20/2020
4	NDC: 73785-001-04	1225000 mL in 1 DRUM; Type 0: Not a Combination Product	03/20/2020
5	NDC: 73785-001-05	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/20/2020

Labeler - Pernod Ricard USA (797052383)

Establishment
Name	Address	ID/FEI	Business Operations
Firestone and Robertson Distillery		022014598	manufacture(73785-001)

Establishment
Name	Address	ID/FEI	Business Operations
Rabbit Hole Spirits		081311267	manufacture(73785-001)

Establishment
Name	Address	ID/FEI	Business Operations
Pernod Ricard USA		797052383	manufacture(73785-001)

Establishment
Name	Address	ID/FEI	Business Operations
Smooth Ambler Spirits		961728388	manufacture(73785-001)