FOAMING ALCOHOL HAND SANITIZER- ethyl alcohol solution

Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient - Ethyl Alcohol 62% v/v

PURPOSE

Purpose - Antbacterial Agent

INDICATIONS & USAGE

Uses - Hand sanitizer to help reduce bacteria on the skin that could cause disease.

WARNINGS

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

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

DOSAGE & ADMINISTRATION

Directions

Apply small amount to palm. Briskly rub, covering hands with product until dry.

INACTIVE INGREDIENT

Inactive Ingredients - Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING ALCOHOL HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78641-688
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISODIUM EDTA-COPPER CU-64 (UNII: 4J875U5U11)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78641-688-78	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2020
2	NDC: 78641-688-50	1200 mL in 1 BAG; Type 0: Not a Combination Product	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/16/2020

Labeler - Global Equipment Company (001472216)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(78641-688)