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Itchy Eye by Meijer Distribution Inc

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: Meijer Distribution Inc
NDC Code: 41250-303

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

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.

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

Questions or comments?

1-800-932-5676

Serious side effects associated with use of this product may be reported to this number

Principal Display Panel Text for Container Label:

NDC 41250-303-01

Meijer Logo

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution 0.035%

Antihistamine

Eye Drops

10 mL

0.34 FL OZ

STERILE

Principal Display Panel Text for Carton Label:

NDC 41250-303-01 Compare to Alaway®

active ingredient*

Meijer Logo

UP TO 12

HOURS OF RELIEF

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Works in Minutes

Original Prescription Strength

For ages 3 years and older

60-day supply

10 mL 0.34 FL OZ STERILE

ITCHY EYE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-303
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (Ketotifen) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
glycerin 
water 
hydrochloric acid 
sodium hydroxide 
Packaging
#Item CodePackage Description
1NDC:41250-303-011 BOTTLE, DROPPER in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/26/2016
Labeler - Meijer Distribution Inc (006959555)

 
Meijer Distribution Inc

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Medically reviewed on Nov 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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