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Zaditor by A-S Medication Solutions

Medically reviewed on Nov 9, 2017

Dosage form: solution
Ingredients: KETOTIFEN FUMARATE .35mg in 1mL
Labeler: A-S Medication Solutions
NDC Code: 50090-1037

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

WARNINGS SECTION

For external use only

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION
  • 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 between 4°-25°C (39°-77°F).

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

HOW SUPPLIED

Product: 50090-1037

NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER

QUESTIONS?

call toll-free
1-800-757-9195
MedInfo@AlconLabs.com
www.zaditor.com
Serious side effects associated with use of this product may be reported to this number.

ketotifen fumarate
ZADITOR  
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1037(NDC:0065-4011)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Glycerin 
Sodium Hydroxide 
Hydrochloric Acid 
Water 
Packaging
#Item CodePackage Description
1NDC:50090-1037-01 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07720012/21/2012
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-1037)

 
A-S Medication Solutions

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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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