ANTI-BACTERIAL HAND SANITIZER- ethyl alcohol gel

Anti-Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Anti-Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fun Zone, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:
Ethyl Alcohol 63%

PURPOSE

Purpose:
Antiseptic

WARNINGS

Warnings:
For external use only. Flammable, keep away from fire, flame and direct sunlight.

STOP USE

Stop using this product and consult a doctor If irritation or redness develops.Stop using this product and consult a doctor If irritation or redness develops.

DOSAGE & ADMINISTRATION

Directions

• Rub dime sized amount between hands until dry.
• For use by children under 6 years, adult supervision is required.

INACTIVE INGREDIENT

Water, Propylene Glycol, Carbomer, Aminomethyl Propanol, Glycerin, Denotonium Benzoate

INDICATIONS & USAGE

Uses To help reduce bacteria on hands.

WHEN USING

When using this product Avoid contact with eyes and lips. If contact occurs, rinse with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69583-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69583-003-00	29 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/12/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/12/2015

Labeler - Fun Zone, Inc. (803572929)