Eye Itch Relief by Cardinal Health / Akorn, Inc. / Akorn, Inc

Eye Itch Relief by

Drug Labeling and Warnings

Eye Itch Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health , Akorn, Inc., Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Cardinal Health

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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).

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Questions or comments?

1-800-932-5676

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NDC: 49781-075-71

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ORIGINAL PRESCRIPTION STRENGTH

Eye Itch Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Sterile

0.17 FL OZ (5 mL)

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NDC: 49781-075-71

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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)

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EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49781-075
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
hydrochloric acid (UNII: QTT17582CB)  
sodium hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49781-075-711 in 1 CARTON01/13/201407/01/2017
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/13/201407/01/2017
Labeler - Cardinal Health (097537435)

Revised: 1/2014
 
Cardinal Health