Label: PRE FENSE- benzalkonium chloride liquid
- NDC Code(s): 48404-051-01, 48404-051-02, 48404-051-03, 48404-051-04
- Packager: Prefense LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 2, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warning:
- Keep out of reach of children
- Directions:
- Inactive Ingredients:
- Package Label - 1 Liter Pouch
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INGREDIENTS AND APPEARANCE
PRE FENSE
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48404-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 120 mg in 100 mL Inactive Ingredients Ingredient Name Strength ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4) METHYL ALCOHOL (UNII: Y4S76JWI15) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) ORANGE OIL (UNII: AKN3KSD11B) (3-CHLOROPROPYL)TRIMETHOXYSILANE (UNII: T21BNL1S7F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48404-051-01 44.4 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 2 NDC:48404-051-02 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 3 NDC:48404-051-03 1000 mL in 1 POUCH; Type 0: Not a Combination Product 05/11/2020 4 NDC:48404-051-04 1893 mL in 1 JUG; Type 0: Not a Combination Product 05/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 05/11/2020 Labeler - Prefense LLC (832498625) Registrant - Prefense LLC (832498625) Establishment Name Address ID/FEI Business Operations Reynolds Engineering and Equipment, Inc. 807186333 manufacture(48404-051)