![ZADITOR (KETOTIFEN FUMARATE) SOLUTION [A-S MEDICATION SOLUTIONS]](https://medic.hrt.org//dailymed/images/7a00b07f-3bc6-47be-8063-b2b076c69191/lbl500901037.jpg)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
- WARNINGS SECTION
For external use only
CloseDo 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
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- 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
- INACTIVE INGREDIENT SECTION
benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid
Close - HOW SUPPLIED
- QUESTIONS?
call toll-free
Close
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
- INGREDIENTS AND APPEARANCE
ZADITOR
ketotifen fumarate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1037(NDC:0065-4011) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN .35 mg in 1 mL Inactive Ingredients Ingredient Name Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) Glycerin (UNII: PDC6A3C0OX) Sodium Hydroxide (UNII: 55X04QC32I) Hydrochloric Acid (UNII: QTT17582CB) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1037-0 1 in 1 CARTON 11/28/2014 1 5 mL in 1 BOTTLE, DROPPER ; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077200 12/21/2012 Labeler - A-S Medication Solutions (830016429) CloseEstablishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-1037)
