Hand Sanitizer by Aerofil Technology Inc. HAND SANITIZER solution

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Hea
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Toba
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Hand Sanitizer Ethyl Alcohol Drug Facts Label

Alcohol 80% v/v.

Purpose Section

Antiseptic, Hand Sanitizer

Indications & Usage Section

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

Warnings Section

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 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 Section

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)

Inactive Ingredients Section

glycerin, hydrogen peroxide, purified water USP

Package Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73849-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	1 mL  in 1 mL

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: 73849-0001-2	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2020

Labeler - Aerofil Technology Inc. (186156048)

Registrant - Aerofil Technology Inc. (186156048)

Establishment
Name	Address	ID/FEI	Business Operations
Aerofil Technology Inc.		186156048	manufacture(73849-0001)