HAND SANITIZER FOR HEALTHCARE- alcohol solution

Hand Sanitizer for Healthcare by

Drug Labeling and Warnings

Hand Sanitizer for Healthcare by is a Otc medication manufactured, distributed, or labeled by American Chemical Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

WARNINGS

Warnings
For external use only. Flammable. Keep away from heat or flame.

Do not use

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

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.

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.

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water

SPL UNCLASSIFIED SECTION

American Chemical Solutions, LLC
2406 Roberts Street

Muskegon, MI 49444

PRINCIPAL DISPLAY PANEL

AMERICAN CHEMICAL SOLUTIONS
Hand Sanitizer for Healthcare
Alcohol Antiseptic 80% Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
1 US Gallon (3.8 L)

INGREDIENTS AND APPEARANCE

HAND SANITIZER FOR HEALTHCARE 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74878-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74878-001-01	3.8 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/08/2020
2	NDC: 74878-001-02	208 L in 1 DRUM; Type 0: Not a Combination Product	04/08/2020
3	NDC: 74878-001-03	1022 L in 1 CONTAINER; Type 0: Not a Combination Product	04/08/2020
4	NDC: 74878-001-04	1249 L in 1 CONTAINER; Type 0: Not a Combination Product	04/08/2020
5	NDC: 74878-001-05	0.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/08/2020

Labeler - American Chemical Solutions LLC (055776494)

Establishment
Name	Address	ID/FEI	Business Operations
American Chemical Solutions LLC		055776494	manufacture(74878-001)