ITCHY EYE DROPS- ketotifen fumarate solution/ drops 
Amerisource Bergen

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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).

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 46122-146-64

GOOD NEIGHBOR PHARMACY Logo® Sterile

Itchy Eye Drops

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

0.17 fl oz (5 mL)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 46122-146-64

Compare to Zyrtec®

Itchy Eye Drops

active ingredient*

GOOD NEIGHBOR PHARMACY Logo®

► 30 DAY SUPPLY

Itchy Eye

Drops

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

Up to 12 hours

Allergy itchy eye relief

Works in minutes

Original Prescription Strength

For ages 3 years & older

Sterile

0.17 fl oz

(5 mL)

Principal Display Panel Text for Carton Label
ITCHY EYE DROPS 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-146
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:46122-146-641 in 1 CARTON12/06/201301/31/2017
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795812/06/201301/31/2017
Labeler - Amerisource Bergen (007914906)

Revised: 10/2020
Document Id: 10e91ddb-4d81-4286-a65c-e7756a7fdb59
Set id: 4d144a0b-8743-458d-96b1-d3920491401f
Version: 2
Effective Time: 20201021
 
Amerisource Bergen