FOTE UNSCENTED HAND SANITIZER- alcohol aerosol, spray

FOTE Unscented Hand Sanitizer by

Drug Labeling and Warnings

FOTE Unscented Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fruit of the Earth, Inc.. 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 while smoking.

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

Stop use and a doctor if

rash or irritation 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

• 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

Questions?

1-800-527-7731

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOTE UNSCENTED HAND SANITIZER 
alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-054
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-054-37	156 g in 1 CAN; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2020

Labeler - Fruit of the Earth, Inc. (079559467)

Registrant - Fruit Of The Earth Research Laboratories, Inc. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		079559467	manufacture(62217-054)