RX200 FOAMING INSTANT HAND SANITIZER- benzalkonium chloride liquid

RX200 Foaming Instant Hand Sanitizer by

Drug Labeling and Warnings

RX200 Foaming Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by The Bullen Companies, Inc., Kutol Products Company, Inc., Kutol Products Company, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

Products 17 & 78: For handwashing to decrease bacteria on skin.

Product 41: Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Purpose

Products 17 & 78: Antibacterial Agent

Product 41: Antibacterial Handwashing

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Warnings

Products 17 & 41: For external use only.Avoid contact with eyes. If contact occurs, flush with water. Stop use and ask a doctor if, in rare instances, redness or irritations develops. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Product 78: For external use only.Do not use in the eyes. In rare instances of redness or irritation, discontinue use. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Inactive Ingredients

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

Directions

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

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RX200 FOAMING INSTANT HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57356-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	4.918 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	18.915 g  in 100 mL
WATER (UNII: 059QF0KO0R)	98.258 mL  in 100 mL
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)	4.918 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	18.915 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	15.132 g  in 100 mL
MONOSODIUM ETHYLENEDIAMINETETRAACETATE (UNII: KBO8XM1K0V)	1.51318 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.000083 g  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.000083 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57356-207-17	50 mL in 1 BOTTLE, PUMP
2	NDC: 57356-207-41	1000 mL in 1 POUCH
3	NDC: 57356-207-78	950 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/14/2009

Labeler - The Bullen Companies, Inc. (002373462)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc		004236139	manufacture(57356-207) , analysis(57356-207) , pack(57356-207)