1. Home
  2. Labeler Index
  3. Cvs Pharmacy
  4. 59779-627
  5. Label Information: Ketotifen Fumarate

FDA Label for Ketotifen Fumarate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ketotifen Fumarate Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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 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, Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.


Questions Or Comments?



1-800-932-5676


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

CVS Health™ Logo

NDC 59779-627-01

Eye Itch Relief

Antihistamine

eye drops

KETOTIFEN FUMARATE

OPHTHALMIC

SOLUTION STERILE

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label:

CVS Health™ Logo Compare to the active

ingredient in Zaditor®*

NDC 59779-627-01

Original Prescription Strength

Eye Itch

Relief

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

Antihistamine eye drops

GET UP TO

12

HOUR

RELIEF

• Works in minutes

• 30 day supply

• For ages 3 years & up

STERILE

5 mL (0.17 FL OZ)


* Please review the disclaimer below.