- 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?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-115(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:71205-115-05 1 in 1 CARTON 09/04/2018 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 - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-115)