EYE ITCH RELIEF- ketotifen fumarate solution 
CVS Pharmacy

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CVS Pharmacy, Inc. Eye Itch Relief Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

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. (1-800-222-1222)

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 20-25°C (68-77°F) [see USP Controlled Room Temperature]

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Zaditor®

EYE ITCH RELIEF

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION

ANTIHISTAMINE EYE DROPS

Original prescription strength

For ages 3 yrs. and older

30 day supply

GET UP TO 12 HOURS OF RELIEF

Sterile

Eye Itch Relief Carton Image
EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-982
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-982-01 1 in 1 CARTON
1 5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 09/14/2010
Labeler - CVS Pharmacy (062312574)

Revised: 4/2013
Document Id: 5551bfea-ac81-4745-a2a3-3bc99347aeb1
Set id: 1accbb46-1377-4043-ab6c-58f04439bc95
Version: 2
Effective Time: 20130408
 
CVS Pharmacy