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Ketotifen Fumarate by Akorn, Inc.

Medically reviewed on Nov 20, 2017

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: Akorn, Inc.
NDC Code: 17478-717

Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

Antihistamine

Use

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.

Directions
  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

Principal Display Panel Text for Container Label:

NDC 17478-717-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Carton Label:

Now OTC! NDC 17478-060-12

Akorn Logo

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-717
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:17478-717-101 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795810/01/2007
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn AG482198285MANUFACTURE(17478-717), ANALYSIS(17478-717), PACK(17478-717), LABEL(17478-717)
Establishment
NameAddressID/FEIOperations
Akorn, Inc.603980319MANUFACTURE(17478-717), REPACK(17478-717), ANALYSIS(17478-717), LABEL(17478-717), PACK(17478-717), RELABEL(17478-717), STERILIZE(17478-717)

 
Akorn, Inc.

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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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