Label: KETOTIFEN FUMARATE solution/ drops
- NDC Code(s): 70518-1142-0
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 17478-717
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 25, 2022
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- 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?
-
PRINCIPAL DISPLAY PANEL
DRUG: Ketotifen Fumarate
GENERIC: Ketotifen Fumarate
DOSAGE: SOLUTION/ DROPS
ADMINSTRATION: OPHTHALMIC
NDC: 70518-1142-0
PACKAGING: 5 mL in 1 BOTTLE, DROPPER
OUTER PACKAGING: 1 in 1 CARTON
ACTIVE INGREDIENT(S):
- ketotifen fumarate 0.35mg in 1mL
INACTIVE INGREDIENT(S):
- benzalkonium chloride
- glycerin
- water
- hydrochloric acid
- sodium hydroxide
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INGREDIENTS AND APPEARANCE
KETOTIFEN FUMARATE
ketotifen fumarate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-1142(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:70518-1142-0 1 in 1 CARTON 04/27/2018 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 04/27/2018 Labeler - REMEDYREPACK INC. (829572556)