EYE ITCH- ketotifen fumarate solution/ drops 
Meijer Distribution Inc

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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 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).

Telephone Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 41250-302-01

Meijer Logo™

Eye Itch Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine

Eye Drops

0.17 FL OZ

(5 mL)

Sterile

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 41250-302-01

Compare to

Zaditor®

active ingredient*

Meijer Logo™

Original

Prescription

Strength

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours of Relief

Works in Minutes

For ages 3 years and older

30 day supply

Sterile

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label
EYE ITCH 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41250-302
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 DescriptionMarketing Start DateMarketing End Date
1NDC:41250-302-011 in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/23/2014
Labeler - Meijer Distribution Inc (006959555)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(41250-302), ANALYSIS(41250-302), STERILIZE(41250-302), PACK(41250-302), LABEL(41250-302)

Revised: 1/2014
Document Id: 1c743727-7a03-4a0c-87c3-1641835ce38c
Set id: fc430abb-a2ed-45e5-832a-d40d1882da11
Version: 1
Effective Time: 20140121
 
Meijer Distribution Inc