good sense eye itch relief

Dosage form: solution
Ingredients: KETOTIFEN FUMARATE 0.25mg in 1mL
Labeler: L Perrigo Company
NDC Code: 0113-0923

Perrigo Eye Itch Relief 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.

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. (1-800-222-1222)

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 at 20-25°C (68-77°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? 1-800-719-9260

Package/Label Principal Display Panel

Works in Minutes

Eye Itch Relief

Ketotifen Fumerate Opthalmic Solution

Antihistimine Eye Drops

Up To 12 Hours

For Ages 3 Years and Older

# Day Supply {Replace "#" with the number day supply in the package}

Original Prescription Strength

Compare to active ingredient of Zaditor®

Sterile

Eye Itch Relief Carton Image 1

Eye Itch Relief Carton Image 2

GOOD SENSE EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0923
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:0113-0923-011 BOTTLE (BOTTLE) in 1 CARTON
15 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795809/15/2010
Labeler - L Perrigo Company (006013346)

Revised: 06/2012
 
L Perrigo Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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