Label: RX200 FOAMING INSTANT HAND SANITIZER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57356-207-17, 57356-207-41, 57356-207-78 - Packager: The Bullen Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 26, 2013
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- Uses
- Purpose
- Active Ingredient
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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
- Directions
- Warnings
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RX200 FOAMING INSTANT HAND SANITIZER
benzalkonium chloride liquidProduct 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)
