HAND SANITIZER- 62% ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Dosage and Administration

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

Inactive Ingredient Section

Inactive Ingredients Water, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Aminomethylpropanol

Indications and Usage Section

Uses For hand cleaning to decrease bacteria on skin.

Keep Out Of Reach Of Children Section

Keep Out Of Reach Of Children If swallowed, contact a physician or poison center.

Purpose Section

Purpose Antibacterial Agent

Active Ingredient Section

Active Ingredient Ethyl Alcohol 62% v/v

Warnings Section

Warnings

For external use only.

Flammable. Keep away from head or flame.

Do not use in the eyes. In case of contact rinse thoroughly.

Stop and ask a doctor if irritation and redness appears and lasts.

Principal Display Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
62% ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66608-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER 1342 (UNII: 809Y72KV36)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66608-056-35	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/04/2019

Labeler - Kimball Midwest (017906231)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc.		004236139	manufacture(66608-056)