Eye Itch Relief
FDA Label NDC 0363-0610

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Eye Itch Relief (NDC 0363-0610). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, when using this product, otc - stop use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ketotifen (0.025%)

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Uses

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

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

Otc - Stop 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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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.
  • Children under 3 years of age: consult a doctor

Other Information

  • store at 4-25°C (39-77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.

Otc - Questions

Questions or comments?

Toll Free Product Information

Call: 1-800-553-5340

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2013 Walgreen Co.

MADE IN U.S.A.

ITEM 306486

9323100

FU60107

Package Label.Principal Display Panel

Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

STERILE

ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

  • Works in minutes
  • For ages 3 years & older
  • 30-day supply

    • 0.17 FL OZ (5 mL)

    12 UP TO 12 HOURS

    Compare to Zaditor® active ingredient‡‡

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