EZFOAM FOAMING ALCOHOL HAND SANITIZER- foaming hand sanitizer solution

eZFoam Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

eZFoam Foaming Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 62% v/v.......Antibacterial Agent

INACTIVE INGREDIENT

Water, AMP-C8-18 Perfluoroalkylethyl Phosphate, Glycerin.

PURPOSE

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

WARNINGS

For external use only.

FLAMMABLE. Keep away from heat or flames.

Avoid contact with eyes. If eye contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Avoid contact with eyes. If eye contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a physician or poison control center.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EZFOAM FOAMING ALCOHOL HAND SANITIZER 
foaming hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-688
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-688-03	213125 mL in 1 DRUM; Type 0: Not a Combination Product	06/27/2013	01/21/2016
2	NDC: 50865-688-09	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/27/2013
3	NDC: 50865-688-17	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/27/2013
4	NDC: 50865-688-24	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/27/2013
5	NDC: 50865-688-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/27/2013
6	NDC: 50865-688-78	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/27/2013
7	NDC: 50865-688-91	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/27/2013	01/21/2016
8	NDC: 50865-688-50	1200 mL in 1 BAG; Type 0: Not a Combination Product	06/27/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/27/2013

Labeler - Kutol Products Company, Inc. (004236139)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(50865-688) , analysis(50865-688) , label(50865-688) , pack(50865-688)