RX200 FOAMING INSTANT HAND SANITIZER- benzalkonium chloride liquid 
The Bullen Companies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RX200 Foaming Instant Hand Sanitizer

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.

20741BCO Label

57356-207-17.jpg

20778BCO Label

RX200 FOAMING INSTANT HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57356-207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE4.918 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57356-207-1750 mL in 1 BOTTLE, PUMP
2NDC:57356-207-411000 mL in 1 POUCH
3NDC:57356-207-78950 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/14/2009
Labeler - The Bullen Companies, Inc. (002373462)
Registrant - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc004236139manufacture(57356-207) , analysis(57356-207) , pack(57356-207)

Revised: 4/2013
Document Id: f8c07676-35ec-4e55-bbad-e892ad979e65
Set id: 0e70e27d-8882-4b59-9bf7-9b0bbd8f987f
Version: 1
Effective Time: 20130426
 
The Bullen Companies, Inc.