ALCOHOL SANITIZER- foaming alcohol sanitizer solution

Alcohol Sanitizer by

Drug Labeling and Warnings

Alcohol Sanitizer by is a Otc medication manufactured, distributed, or labeled by Chemco Corporation, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

ACTIVE INGREDIENT

Active Ingredient Ethyl Alcohol 62% v/v

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose Antibacterial Agent

WARNINGS

Warnings For external use only. Flammable. Keep away from heat or flames.Avoid contact with eyes. If contact occurs, flush eyes with water. Stop use, and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL SANITIZER 
foaming alcohol sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73782-688
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)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73782-688-10	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/16/2020
2	NDC: 73782-688-14	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2020
3	NDC: 73782-688-24	1000 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 - Chemco Corporation (058342759)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(73782-688)