Ketotifen Fumarate Ophthalmic Solution

Ketotifen Fumarate Ophthalmic Solution
SPL v4
SPL
SPL Set ID b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3
Route
OPHTHALMIC
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketotifen (0.25 mg)
Inactive Ingredients
Benzalkonium Chloride Glycerin Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-10-09

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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

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
Packaging

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.
Questions?

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

Active Ingredient

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

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 and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).


Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Antihistamine

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
Packaging

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.
Questions?

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

Active Ingredient (Active ingredient)

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Other Information (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 (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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