Label: DURISAN- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71120-115-01 - Packager: Sanit Technologies 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 October 8, 2020
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
DURISAN
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71120-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBIC ACID (UNII: X045WJ989B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C VIOLET NO. 2 (UNII: 350KA7O6HK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71120-115-01 300 mL in 1 PACKAGE; Type 0: Not a Combination Product 10/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/08/2020 Labeler - Sanit Technologies LLC (075711022)