Label: TOPSANI- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 24439-321-10, 24439-321-11, 24439-321-12, 24439-321-13 - Packager: United Promotions 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 December 1, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Indications
- Warning
- Directions
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TOPSANI
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24439-321 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.25 mL in 1000 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYSORBATE 20 (UNII: 7T1F30V5YH) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24439-321-10 56 mL in 1 BOTTLE, PLASTIC 2 NDC:24439-321-11 236 mL in 1 BOTTLE, PUMP 3 NDC:24439-321-12 946 mL in 1 BOTTLE, PLASTIC 4 NDC:24439-321-13 946 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 11/01/2011 Labeler - United Promotions Inc. (796252054)
