HAND SANITIZER- alcohol solution

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ava Food Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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

WHEN USING

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.

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.

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)
• You may report serious side effects to 2325 3rd St. #405, San Francisco, CA 94107

Inactive ingredients

glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

60 mL NDC: 74065-001-01

3785 mL NDC: 74065-001-02

3785 mL NDC: 74065-001-03

208000 mL NDC: 74065-001-04

1000000 mL NDC: 74065-001-05

60 mL NDC: 74065-001-06

375 mL NDC: 74065-001-07

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74065-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74065-001-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
2	NDC: 74065-001-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 74065-001-03	3785 mL in 1 POUCH; Type 0: Not a Combination Product	03/30/2020
4	NDC: 74065-001-04	208000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020
5	NDC: 74065-001-05	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
6	NDC: 74065-001-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 74065-001-07	375 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 - Ava Food Labs, Inc. (024506747)

Establishment
Name	Address	ID/FEI	Business Operations
Ava Food Labs, Inc.		024506747	manufacture(74065-001) , pack(74065-001) , label(74065-001)