ALCOHOL BASED HAND SANITIZER- ethyl alcohol solution

Alcohol Based Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Based Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Seattle Sanitizer LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient(s)

Ethyl Alcohol 85% v/v

Purpose

Antiseptic

Use(s)

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

on 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 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.

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 information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• Denatured Alcohol, Ethyl Alcohol 85% as determined by hydrometer.

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

HIGHEST POTENCY 85% ETHANOL

HAND SANITIZER FOR FASTER MORE COMPLETE SANITIZING OF HANDS AND OTHER SURFACES

Highly effective while easy on your skin

FDA APPROVED FORMULA

non sterile solution

MADE IN THE USA

MANUFACTURED BY SKYBOUND SPIRITS
IN SEATTLE WASHINGTON
945 ELLIOT AVE WEST
SEATTLE, WA 98119

WWW.SEATTLESANITIZER.COM

Packaging

INGREDIENTS AND APPEARANCE

ALCOHOL BASED HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78539-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	85 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78539-001-02	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78539-001-04	118.29 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78539-001-08	236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78539-001-16	473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 78539-001-32	1890 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 78539-001-64	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Seattle Sanitizer LLC (130478322)

Establishment
Name	Address	ID/FEI	Business Operations
Seattle Sanitizer LLC		130478322	manufacture(78539-001)