Zaditor Solution
FDA Label NDC 0065-4011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Zaditor (NDC 0065-4011). 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 otc - purpose, indications & usage, warnings, do not use, when using this product, otc - stop use, otc - 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

Otc - Purpose

Active ingredientPurpose
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)		Antihistamine

Indications & Usage

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

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

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 for more than 72 hours

Otc - Keep Out Of Reach Of Children

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 8-12 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 between 4°-25°C (39°-77°F).

Inactive Ingredients

benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

Questions?

In the US, call toll-free 1-800-757-9195

[email protected]
www.systane.com

Serious side effects associated with use of this product may be reported to this number.

Package Label.Principal Display Panel

Systane®
ZADITOR®
ketotifen fumarate ophthalmic solution 0.035%
 
ANTIHISTAMINE EYE DROPS
EYE ITCH RELIEF
 
●   Works in minutes
●   Original prescription strength
●   For ages 3 years and older

up to 12 HOURS

Alcon

STERILE
30 DAY SUPPLY
5mL (0.17 FL OZ)

Original Prescription Strength
Up to 12 Hour Itch Relief
Works in Minutes

For Ages 3 Years and Older

30 DAY SUPPLY

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
a Novartis Division
Country of Origin: Italy

9016645-0918

ACTUAL SIZE

LOT:          EXP.:

Carton2 (Carton2)

Carton2 (Carton2)

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