KETOTIFEN FUMARATE 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:

DIRECT RX

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

OTC DRUG

Käyttöaiheet:

Antihistamine Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

KETOTIFEN FUMARATE- KETOTIFEN FUMARATE SOLUTION
KETOTIFEN FUMARATE- KETOTIFEN FUMARATE SOLUTION/ DROPS
DIRECT RX
----------
KETOTIFEN FUMARATE
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
Antihistamine
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal
hair and dander.
For external use only
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.
Adults and children 3 years of age and older: Put 1 drop in the
affected eye(s) twice
daily, every 8 to 12 hours, no more than twice per day.
Children under 3 years of age: Consult a doctor.
Only for use in the eye.
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room
Temperature].
benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium
hydroxide, and
water for injection
KETOTIFEN FUMARATE
ketotifen fumarate solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:72189-114(NDC:60505-6215)
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN -
UNII:X49220T18G)
KETOTIFEN
0.25 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:72189-
114-05
5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a