EZFoam Foaming Alcohol Hand Sanitizer: Package Insert and Label Information

EZFOAM FOAMING ALCOHOL HAND SANITIZER- alcohol solution
Kutol Products Company, Inc.

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.

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.

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50865-688-03 213125 mL in 1 DRUM None
2 NDC:50865-688-09 3785 mL in 1 JUG None
3 NDC:50865-688-17 50 mL in 1 BOTTLE, PLASTIC None
4 NDC:50865-688-24 1000 mL in 1 BAG None
5 NDC:50865-688-41 1000 mL in 1 BAG None
6 NDC:50865-688-78 950 mL in 1 BOTTLE, PLASTIC None
7 NDC:50865-688-91 532 mL in 1 BOTTLE, PLASTIC None
8 NDC:50865-688-50 1200 mL in 1 BAG None
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 Operations
Kutol Products Company, Inc. 004236139 manufacture (50865-688), analysis (50865-688), label (50865-688), pack (50865-688)

Revised: 01/2020 Kutol Products Company, Inc.

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