Rx200 Foaming Instant Hand Sanitizer (Benzalkonium Chloride) Liquid [The Bullen Companies, Inc.] -

RX200 FOAMING INSTANT HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [THE BULLEN COMPANIES, INC.]
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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.
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INGREDIENTS AND APPEARANCE

RX200 FOAMING INSTANT HAND SANITIZER
benzalkonium chloride liquid

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/14/2009

Labeler - The Bullen Companies, Inc. (002373462)

Registrant - Kutol Products Company, Inc. (004236139)

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

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