Eye Itch Relief Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Eye Itch Relief Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Mfr: OTC
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Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% glycerin hydrochloric acid and/or sodium hydroxide and water for injection
Quantities
5 ml
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOX
Packaging

Principal Display Panel Rugby® NDC 0536-1096-40 Compare to Zaditor® Active ingredient* Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution NEW Formula ANTIHISTAMINE EYE DROPS UP TO 12 HOURS ITCH RELIEF • Works in Minutes • Original Prescription Strength For Ages 3 Years & Older 30 Day Supply 5 mL (0.17 FL OZ) STERILE 0.025% carton

Package Descriptions
  • Principal Display Panel Rugby® NDC 0536-1096-40 Compare to Zaditor® Active ingredient* Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution NEW Formula ANTIHISTAMINE EYE DROPS UP TO 12 HOURS ITCH RELIEF • Works in Minutes • Original Prescription Strength For Ages 3 Years & Older 30 Day Supply 5 mL (0.17 FL OZ) STERILE 0.025% carton

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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 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.
Purpose

Purpose Antihistamine

Do Not Use

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

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

Stop Use & Ask a Doctor

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? Write to: Apotex Corp. Consumer Affairs 2400 N. Commerce Pkwy, Suite 400 Weston FL 33326 Or call us at 1-800-706-5575 (Monday to Friday 8:30 am – 5:00 pm Eastern Standard Time)


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