KETOTIFEN FUMARATE- ketotifen fumarate solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Rugby Laboratories

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

OTC DRUG

Chỉ dẫn điều trị:

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

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

KETOTIFEN FUMARATE- KETOTIFEN FUMARATE SOLUTION
RUGBY LABORATORIES
----------
_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_
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.
_DIRECTIONS_
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.
_OTHER INFORMATION_
Only for use in the eye.
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room
Temperature].
_INACTIVE INGREDIENTS_
benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium
hydroxide, and water for
injection
_QUESTIONS OR COMMENTS?_
Call toll-free 1-800-706-5575
Weekdays 8:30 AM - 5:00 PM Eastern Standard Time
PRINCIPAL DISPLAY PANEL - BOTTLE LABEL
Rugby Laboratories
NDC 0536-1222-40
Eye Itch Relief
Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle
PRINCIPAL DISPLAY PANEL - BOTTLE CARTON
Rugby Laboratories
NDC 0536-1222-40
Eye Itch Relief
Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle
KETOTIFEN FUMARATE
ketotifen fumarate solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 536 -1222
Rugby Laboratories
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDI