EYE ITCH RELIEF- ketotifen fumarate solution 
Safeway

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Drug Facts

Active ingredient

Ketotifen 0.025%

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings
For external use only

Do not use

if you are sensitive to any ingredient in this product
if solution changes color or becomes cloudy
to treat contact lens related irritation

When using this product

remove contact lenses before use
wait at least 10 minutes before re-inserting contact lenses after use
do not touch tip of container to any surface to avoid contamination
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 eyes
itching that 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 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

Store at 4-25°C (39-77°F)

Inactive ingredients

Benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.

Questions?

Call: 1-800-553-5340

*This product is not manufactured or distributed by Novartis, distributor of Zaditor.

Package/Label Principal Display Panel – 5mL carton

NDC 21130-601-05

Signature™
Care

Quality Guaranteed

STERILE
ORIGINAL PRESCRIPTON STRENGTH

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
Antihistamine Eye Drops

Compare to the active ingredient in Zaditor*

Up to 12 hours


0.17 FL OZ (5mL)

carton.jpg
EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-601
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-601-051 in 1 CARTON08/20/2014
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199608/20/2014
Labeler - Safeway (009137209)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(21130-601)

Revised: 1/2020
Document Id: 0979de78-5329-41cb-928d-769726f58764
Set id: 5fccbb63-7859-484c-b7b3-9de711364c09
Version: 4
Effective Time: 20200130
 
Safeway