FOAMING INSTANT HAND SANITIZER- 0.13% benzakonium chloride liquid

Foaming Instant Hand Sanitizer by

Drug Labeling and Warnings

Foaming Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by RJ Schinner, Kutol Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration Section

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

Inactive Ingredient Section

Inactive Ingredients: Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheral Acetate, Peg-& Glyceral Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA

Indications and Usage Section

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Intended for repeated use.

Keep Out Of Reach Of Children Section

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

OTC Purpose Section

Purpose: Antibacterial Agent

OTC Active Ingredient Section

Active Ingredient: Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings: For External Use Only

Contact with Eyes: If contact occurs, flush with water

Stop Use if, in rare instances, redness or irritation develop. If condition persists more than 72 hours, contact a physician.

Primary Display Label

INGREDIENTS AND APPEARANCE

FOAMING INSTANT HAND SANITIZER 
0.13% benzakonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-207
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
EDETATE SODIUM (UNII: MP1J8420LU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71303-207-41	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2017
2	NDC: 71303-207-31	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2017

Labeler - RJ Schinner (023432909)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc.		004236139	manufacture(71303-207)