KETOTIFEN FUMARATE OPHTHALMIC SOLUTION- ketotifen fumarate solution/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Armas Pharmaceuticals Inc.

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

OTC DRUG

Käyttöaiheet:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION- KETOTIFEN FUMARATE SOLUTION/
DROPS
ARMAS PHARMACEUTICALS INC.
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KETOTIFEN FUMARATE OPHTHALMIC SOLUTION
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ketotifen (0.025%)
(equivalent to Ketotifen Fumarate 0.035%)
_PURPOSE_
Antihistamine
_USE_
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).
_QUESTIONS?_
call toll-free 1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT
NOW _OTC!_
ANTIHISTAMINE EYE DROPS
UPTO 12 HOURS EYE ITCH RELIEF
• WORKS IN MINUTES
• ORIGINAL PRESCRIPTION STRENGTH
FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY
STERILE
ORIGINAL PRESCRIPTION STRENGTH
DO NOT USE IF SEAL ON BOTTLE IS MISSING OR BROKEN.
FOR TOPICAL OPHTHALMIC USE ONLY.
PRECAUTION: DO NOT TOUCH DROPPER TIP TO ANY SURFACE, AS THIS MAY
CONTAMINATE THE SOLUTION.
DISTRIBUTED BY: ARMAS PHARMACEUTICALS, INC.
FREEHOLD, NJ 07728 (USA)
MANUFACTURED BY: OPHTAPHARM AG, RI