FOAMING INSTANT HAND SANITIZER- benzalkonium chloride solution

Foaming Instant Hand Sanitizer by

Drug Labeling and Warnings

Foaming Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Global Equipment Company, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Benzalkonium Chloride 0.13% w/w

PURPOSE

Purpose Antibacterial Agent

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

Directions

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

FOAMING INSTANT HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78641-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78641-207-78	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2020
2	NDC: 78641-207-50	1200 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	part333E	03/16/2020

Labeler - Global Equipment Company (001472216)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(78641-207)