KETOTIFEN FUMARATE solution/ drops

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)

Dostępny od:

KAISER FOUNDATION HOSPITALS

INN (International Nazwa):

ketotifen fumarate

Skład:

Ketotifen 0.35 mg in 1 mL

Droga podania:

OPHTHALMIC

Typ recepty:

OTC DRUG

Wskazania:

Antihistamine Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

KETOTIFEN FUMARATE- KETOTIFEN FUMARATE SOLUTION/ DROPS
KAISER FOUNDATION HOSPITALS
----------
DRUG FACTS
ACTIVE INGREDIENT
Ketotifen (0.025%) (equivalent to Ketotifen Fumarate 0.035%)
PURPOS E
Antihistamine
US E
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.
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° to 25°C (68° to 77°F) [see USP Controlled Room
Temperature].
INACTIVE INGREDIENTS
Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May
contain Hydrochloric Acid
and/or Sodium Hydroxide (to adjust pH).
QUES TIONS ?
call toll-free 1-800-932-5676, weekdays, 7:00 AM -5:30 PM CST
Principal Display Panel Text for Container Label:
NDC 0179-8601-05
KAISER PERMANENTE Logo
Ketotifen Fumarate
Ophthalmic Solution
Antihistamine Eye Drop
5 mL (0.17 FL OZ) Sterile
Principal Display Panel Text for Carton Label:
NDC 0179-8601-05
KAISER PERMANENTE Logo
Ketotifen
Fumarate
Ophthalmic Solution
Antihistamine
Eye drop
Up to 12 hours of
eye itch relief
0.025% Sterile solution
*Compare to Zaditor
5 mL (0.17 FL OZ)
®
®
®
KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOU