Equate Eye Itch Relief

Equate Eye Itch Relief is an FDA drug label for the active ingredient KETOTIFEN FUMARATE manufactured by Wal-Mart Stores, Inc. administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210323.

Generic: KETOTIFEN FUMARATE

Manufacturer: Wal-Mart Stores, Inc.

Product Type: HUMAN OTC DRUG

Route: OPHTHALMIC

Dosage Form:

NDC: 49035-231

Application: NDA021996

Effective: 20210323

Active Ingredients: Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

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 or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: consult a doctor Other information Store at 4-25°C (39-77°F)

Contraindications

Not available.

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

Adverse Reactions

Not available.

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