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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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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