Label: FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER- benzalkonium chloride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 76116-100-01 - Packager: First Dephense, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 28, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76116-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76116-100-01 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 01/13/2011 Labeler - First Dephense, LLC (028165717) Establishment Name Address ID/FEI Business Operations American Blending and Filling 809226710 manufacture