Active Ingredient(s)

Ethanol 62% v/v.

Purpose

Antiseptic

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

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

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.

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.

Purified Water USP, Glycerin, PEG-10, Dimethicone, Fragrance

1000 mL NDC: 79667-001-10

1000 mL Front

1000 mL NDC: 79667-001-10

1000 mL Back

HAND SANITIZER
alcohol solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79667-001-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/08/2020

Labeler - ELEFTHERIA LLC (117585354)

Name	Address	ID/FEI	Business Operations
Establishment
Alpha Aromatics		041723545	manufacture(79667-001)