Label: ANTIBACTERIAL HAND- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76273-001-01, 76273-001-02 - Packager: MAYBORN USA, 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 July 27, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76273-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) LACTIC ACID (UNII: 33X04XA5AT) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76273-001-01 50 mL in 1 BOTTLE, PLASTIC 2 NDC:76273-001-02 150 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/27/2011 Labeler - MAYBORN USA, INC. (031274363) Establishment Name Address ID/FEI Business Operations ORGANICA (UK) LTD 235330151 manufacture
