Hand Sanitizer by State Industrial Products / Kutol Products Company HAND SANITIZER solution

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. Recommended for repeated use.

ACTIVE INGREDIENT

Active Ingredient Benzalkonium Chloride 0.13% v/v

WARNINGS

Warnings For external use only. Avoid contact with eyes. If 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.

INACTIVE INGREDIENT

Inactive Ingredients Water, Propylene Glycol, Fragrance, Tocopheryl Acetate, Tetrasodium EDTA, Cocamidoprpyl Betaine, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

PURPOSE

Purpose Antibacterial Agent

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64542-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
PROPYLENE GLYCOL 1-MYRISTATE (UNII: 5G38I12XFT)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64542-207-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	02/14/2019
2	NDC: 64542-207-17	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2019
3	NDC: 64542-207-46	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2019
4	NDC: 64542-207-91	547 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/14/2019

Labeler - State Industrial Products (004520987)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(64542-207)