FOAMING HAND SANITIZER- alcohol-free foaming hand sanitizer solution

Foaming Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

ACTIVE INGREDIENT

Active Ingredient Benzalkonium Chloride 0.13 v/v

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

PURPOSE

Purpose Antibacterial Handwashing

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING HAND SANITIZER 
alcohol-free foaming hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73782-207
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
PROPYLENE GLYCOL 2-MYRISTATE (UNII: 8P46CF5SA5)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73782-207-10	1000 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	part333A	03/16/2020

Labeler - Chemco Corporation (058342759)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(73782-207)