UP AND UP EYE ITCH RELIEF ketotifen fumarate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)

Available from:

Target Corporation

INN (International Name):

KETOTIFEN FUMARATE

Composition:

KETOTIFEN 0.25 mg in 1 mL

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

UP AND UP EYE ITCH RELIEF- KETOTIFEN FUMARATE SOLUTION
TARGET CORPORATION
----------
TARGET CORPORATION EYE ITCH RELIEF DRUG FACTS
ACTIVE INGREDIENT
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
PURPOS E
Antihistamine
US ES
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?
1-800-910-6874
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
eye itch relief
ketotifen fumarate ophthalmic solution
antihistamine eye drops
Compare to active ingredient in Zaditor®
up to 12 hours
original prescription strength
for ages 3 years and older
30 day supply
sterile
EYE ITCH RELIEF CARTON IMAG E 1
Target Corporation
EYE ITCH RELIEF CARTON IMAG E 2
UP AND UP EYE ITCH RELIEF
ketotifen fumarate solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:116 73-9 23
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BA