Label: KETOTIFEN FUMARATE solution/ drops
- NDC Code(s): 50090-2900-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 17478-717
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 10, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
-
Warnings
Do not use
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
When using this product
- do not touch tip of container to any surface to avoid contamination
- remove contact lenses before use
- wait at least 10 minutes before reinserting contact lenses after use
- replace cap after each use
- Directions
- Other information
- Inactive ingredients
- Questions?
- HOW SUPPLIED
- Ketotifen Fumarate
-
INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2900(NDC:17478-717) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.35 mg in 1 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride (UNII: F5UM2KM3W7) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) hydrochloric acid (UNII: QTT17582CB) sodium hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2900-0 1 in 1 CARTON 03/03/2017 1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077958 10/01/2007 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-2900)