HAND SANITIZER- alcohol aerosol, spray

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on the skin that could cause disease.

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 to remove.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

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

• spray enough product in palm to thoroughly cover your hands
• rub hands together briskly until dry
• children under 6 years of age should be supervised when using this product.

Other information

• may discolor or damage some fabrics/materials or surfaces.
• Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients

water, glycerin, aloe barbadensis leaf juice, tocopheryl acetate

Package Label - Principal Display Panel

5.5 OZ (156g) NDC: 36800-945-37

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-945
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-945-37	156 g in 1 CAN; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

Labeler - TOPCO (006935977)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(36800-945)