Drugplain

Eye Itch Relief .25 mg/mL

Ketotifen Fumarate · SOLUTION/ DROPS · CVS Pharmacy

2 Recalls on Record
Plain English

Eye Itch Relief is a solution/ drops containing ketotifen fumarate at .25 mg/mL, taken ophthalmic. Manufactured by CVS Pharmacy.

Key Facts

Brand Name
Eye Itch Relief
Generic Name
Ketotifen Fumarate
NDC Code (Product)
69842-275
Manufacturer
CVS Pharmacy
Strength
.25 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
NDA021996
Marketing Start
04/01/2020

Recall History

2 Recalls on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II09/03/2020

Akorn, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective178 reports
treatment failure141 reports
pruritus125 reports
urticaria112 reports
nausea88 reports
dyspnoea86 reports
fatigue84 reports
diarrhoea83 reports
hypersensitivity81 reports
headache80 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Dosage & Administration

Directions Adults and children 3 years and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product Children under 3 years of age: consult a doctor

Warnings

Warnings For external use only Do not use if you are sensitive to any ingredient in this product if solution changes color or becomes cloudy to treat contact lens related irritation When using this product remove contact lenses before use wait at least 10 minutes before re-inserting contact lenses after use do not touch tip of container to any surface to avoid contamination 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 eyes itching that worsens or lasts for more than 72 hours

Frequently Asked Questions

What is Eye Itch Relief used for?

Eye Itch Relief contains Ketotifen Fumarate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Eye Itch Relief a controlled substance?

Eye Itch Relief is not classified as a controlled substance by the DEA.

What is the generic name for Eye Itch Relief?

The generic name for Eye Itch Relief is Ketotifen Fumarate. There are 5 other brand versions of Ketotifen Fumarate.

What is the NDC code for Eye Itch Relief .25 mg/mL?

The NDC (National Drug Code) for Eye Itch Relief .25 mg/mL is 69842-275, listed by CVS Pharmacy.