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Eye Itch Relief by Cardinal Health

Medically reviewed on January 10, 2018

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: Cardinal Health
NDC Code: 49781-075

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).

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 49781-075-71

LEADER Logo®

ORIGINAL PRESCRIPTION STRENGTH

Eye Itch Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Sterile

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label:

NDC 49781-075-71

LEADER Logo®

Compare to

Zaditor®

active ingredient*

ORIGINAL

PRESCRIPTION

STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

Itch Relief

  • WORKS IN MINUTES
  • For Ages 3 Years & Older
  • 30 Day Supply

Sterile

SATISFACTION

GUARANTEED Logo

0.17 FL OZ (5 mL)

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-075
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:49781-075-711 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/13/2014
Labeler - Cardinal Health (097537435)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(49781-075), ANALYSIS(49781-075), STERILIZE(49781-075), PACK(49781-075), LABEL(49781-075)

 
Cardinal Health

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Further information

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

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