ZADITOR - ketotifen fumarate solution 
A-S Medication Solutions

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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

STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE ANY OF THE FOLLOWING

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

OTHER INFORMATION

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

Label Image
ZADITOR  
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1037(NDC:0065-4011)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Hydrochloric Acid (UNII: QTT17582CB)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-1037-01 in 1 CARTON11/28/2014
15 mL in 1 BOTTLE, DROPPER ; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07720012/21/2012
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1037)

Revised: 11/2017
Document Id: 06e5bdc8-93d0-4ffd-9349-d0f54cbc8fb3
Set id: 7a00b07f-3bc6-47be-8063-b2b076c69191
Version: 5
Effective Time: 20171109
 
A-S Medication Solutions