Ketotifen Fumarate Ophthalmic Solution KETOTIFEN FUMARATE ARMAS PHARMACEUTICALS INC. FDA Approved Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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Substance Ketotifen Fumarate
Route
OPHTHALMIC
Applications
ANDA077958
Package NDC

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 and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0372485617104
UNII
HBD503WORO
Packaging

Packaging Ketolbl3

Package Descriptions
  • Packaging Ketolbl3

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 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.

Warnings & Precautions
Warnings 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 for 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

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.

Storage & Handling

Other information Only for use in the eye. Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].

Questions

Questions? call toll-free 1-855-473-6847, weekdays, 7:00 AM - 5:30 PM CT


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