Label: AQUACIL- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81232-170-03, 81232-170-08, 81232-170-10, 81232-170-16, view more81232-170-17, 81232-170-37, 81232-170-43 - Packager: Biocentris Pharmaceuticals, LLC
- 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 June 7, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AQUACIL
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81232-170 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 g in 100 mL Inactive Ingredients Ingredient Name Strength CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81232-170-03 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2013 2 NDC:81232-170-08 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2013 06/07/2021 3 NDC:81232-170-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013 06/07/2021 4 NDC:81232-170-37 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2013 06/07/2021 5 NDC:81232-170-43 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 05/01/2013 6 NDC:81232-170-10 1000 mL in 1 POUCH; Type 0: Not a Combination Product 05/01/2013 7 NDC:81232-170-17 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2013 Labeler - Biocentris Pharmaceuticals, LLC (015882747)