Zaditor

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-800-757-9195

Websitewww.zaditor.comwww.zaditor.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

Do Not Use

SPL UNCLASSIFIED SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• eye pain
• changes in vision
• redness of the eye
• itching worsens or lasts for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY INFORMATION

• Only for use in the eye.
• Store between 4°-25°C (39°-77°F).

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerol, purified water, sodium hydroxide and/or hydrochloric acid

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1037

NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER

QUESTIONS?

OTC - QUESTIONS SECTION

call toll-free
1-800-757-9195
MedInfo@AlconLabs.com
www.zaditor.com
Serious side effects associated with use of this product may be reported to this number.

ketotifen fumarate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

• Zaditor
• ketotifen fumarate
• KETOTIFEN
• Benzalkonium Chloride
• Glycerin
• Sodium Hydroxide
• Hydrochloric Acid
• Water

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

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Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.