ezFoam Foaming Alcohol Hand Sanitizer

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 RJ Schinner, Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EZFOAM FOAMING ALCOHOL HAND SANITIZER- foaming hand sanitizer solution 
RJ Schinner

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ezFoam Foaming Alcohol Hand Sanitizer

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

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

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

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.

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

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. If swallowed, contact a physician or poison control center.

EZFOAM FOAMING ALCOHOL HAND SANITIZER 
foaming hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-001
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: 71303-001-01	213125 mL in 1 DRUM; Type 0: Not a Combination Product	03/10/2017	01/27/2020
2	NDC: 71303-001-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/28/2017	01/27/2020
3	NDC: 71303-001-04	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	01/27/2020
4	NDC: 71303-001-05	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/10/2017	01/27/2020
5	NDC: 71303-001-06	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/10/2017	01/27/2020
6	NDC: 71303-001-07	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	01/27/2020
7	NDC: 71303-001-08	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	01/27/2020
8	NDC: 71303-001-09	1200 mL in 1 BAG; Type 0: Not a Combination Product	03/10/2017	01/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/10/2017	01/27/2020

Labeler - RJ Schinner (023432909)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(71303-001) , analysis(71303-001) , label(71303-001) , pack(71303-001)

Revised: 1/2020

Document Id: 9d254565-c22c-0d88-e053-2995a90a7e27

34390-5

Set id: 4998922d-258e-6fb4-e054-00144ff8d46c

Version: 2

Effective Time: 20200127

 

RJ Schinner