FOAMING HAND SANITIZER- ethyl alcohol 62% liquid

Foaming Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Dosage & Administration Section

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

Inactive Ingredient Section

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

Indication & Usage Section

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

OTC-Keep Out of Reach of Children

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

Purpose Section

Purpose Antibacterial Agent

OTC - Active Ingredient Section

Active Ingredient Ethyl Alcohol 62% v/v

Warnings Section

Warnings

For external use only.

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.

Principal Display Panel

INGREDIENTS AND APPEARANCE

FOAMING HAND SANITIZER 
ethyl alcohol 62% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-688
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
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71303-688-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2017
2	NDC: 71303-688-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2017

Labeler - RJ Schinner (023432909)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc.		004236139	manufacture(71303-688)