ALLERGY EYE DROPS- 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).

Telephone Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 49781-078-71

LEADER Logo®

ORIGINAL PRESCRIPTION STRENGTH

Allergy Eye Drops

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Sterile

0.17 FL OZ (5 mL)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 49781-078-71

LEADER Logo®

Compare to

Zyrtec®

Itchy Eye Drops

active ingredient*

ORIGINAL

PRESCRIPTION

STRENGTH

Allergy

Eye Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

Allergy Itchy Eye Relief

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

Sterile

SATISFACTION

GUARANTEED Logo

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label
ALLERGY EYE DROPS 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-078
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:49781-078-711 in 1 CARTON01/13/201407/01/2016
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/13/201407/01/2016
Labeler - Cardinal Health (097537435)

Revised: 1/2014
Document Id: 2c2ad027-ac00-4cc3-a01c-f19f3560ae48
Set id: d0a8f488-5193-4aa9-bd77-711fc002b244
Version: 2
Effective Time: 20140110
 
Cardinal Health