FDA
Ketotifen Fumarate
The FDA lists this product in 3 strengths and forms.
Indications
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Warnings and precautions
Warnings For external use only 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 Stop use and ask a doctor if you experience any of the following:
- eye pain
- changes in vision
- redness of the eye
- itching worsens or lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Composition
- Active ingredients
- KETOTIFEN FUMARATE EQ 0.025% BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsANDA077958-001 · Over the counter
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsANDA077354-001 · Discontinued
- KETOTIFEN FUMARATE EQ 0.025% BASE · Solution/dropsThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA204059.
At a glance
- Brand name
- Ketotifen Fumarate
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Unichem
- Status
- Over the counter
- FDA approval
- 1 Jun 2020
- Application
- ANDA204059-001