Eye Itch Relief Solution/ Drops
FDA Label NDC 70000-0124

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Eye Itch Relief (NDC 70000-0124). 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 other, active ingredient, purpose, uses, do not use, when using this product, otc - stop use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

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 the tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lens after use
  • 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 eye
  • itching worsens or lasts 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 of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age: Consult a doctor

Other Information

  • only for use in the eye.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions Or Comments?

1-800-932-5676

Principal Display Panel Text For Container Label:

LEADER™ Logo

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17FL OZ)

Principal Display Panel Text For Carton Label:

LEADER™ Logo

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

of Itch Relief COMPARE TO

Works in Minutes ZADITOR®

Original Prescription ANTIHISTAMINE

Strength EYE DROPS

Active ingredient*

For Ages 3 Years

& Older 100% Money

30-day Supply Back Guarantee

5 mL (0.17 FL OZ)

* Please review the disclaimer below.