HAND SANITIZER- gel hand sanitizer gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by State Industrial Products, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions Apply a 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

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

INACTIVE INGREDIENT

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

WARNINGS

Warnings For external use only. FLAMMABLE. Keep away from heat or flame. Do not use in the eyes. If eye contact occurs, flush with water. Stop and ask a doctor if redness and irritation occur and last more than 72 hours.

PRINCIPAL DISPLAY PANEL

Principal Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64542-056
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)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 1342 (UNII: 809Y72KV36)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64542-056-35	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/09/2020

Labeler - State Industrial Products (004520987)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(64542-056)