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Ketotifen Fumarate by KAISER FOUNDATION HOSPITALS

Medically reviewed on November 27, 2017

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: KAISER FOUNDATION HOSPITALS
NDC Code: 0179-8601

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 Water for Injection. May contain Hydrochloric Acid 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 0179-8601-05

KAISER PERMANENTE® Logo

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drop

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Carton Label:

NDC 0179-8601-05

KAISER PERMANENTE® Logo

Ketotifen

Fumarate

Ophthalmic Solution

Antihistamine

Eye drop

Up to 12 hours of

eye itch relief

0.025% Sterile solution

*Compare to Zaditor®

5 mL (0.17 FL OZ)

KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8601
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:0179-8601-051 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/08/2011
Labeler - KAISER FOUNDATION HOSPITALS (053052619)
Establishment
NameAddressID/FEIOperations
Akorn AG482198285MANUFACTURE(0179-8601), ANALYSIS(0179-8601), PACK(0179-8601), LABEL(0179-8601)
Establishment
NameAddressID/FEIOperations
Akorn, Inc.603980319MANUFACTURE(0179-8601), REPACK(0179-8601), ANALYSIS(0179-8601), LABEL(0179-8601), PACK(0179-8601), RELABEL(0179-8601), STERILIZE(0179-8601)

 
KAISER FOUNDATION HOSPITALS

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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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