Drug Facts

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

WARNINGS SECTION

For external use only

Do not use

• if you are sensitive to any ingredient in this product
• if solution changes color or becomes cloudy
• to treat contact lens related irritation

When using this product

• remove contact lenses before use
• wait at least 10 minutes before re-inserting contact lenses after use
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor ifyou experience any of the following:

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 3 years and older:
  • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
  • if using other ophthalmic products while using this, wait at least 5 minutes between each product
• Children under 3 years of age:consult a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at 4-25°C (39-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions or comments?

OTC - QUESTIONS SECTION

[phone icon] Call: 1-866-767-9161

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69842-275-10

[heart icon] CVS™

UP TO
12
HOURS

Original Prescription Strength

EYE ITCH
RELIEF

Ketotifen Fumarate
Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Compare to the active

Ingredient in Alaway®*

Works in minutes For ages 3 years & older

0.034 FL OZ (10 mL)

STERILE

DailyMed Product Concepts#

Products#

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

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

• Eye Itch Relief
• Ketotifen Fumarate
• KETOTIFEN
• BENZALKONIUM CHLORIDE
• GLYCERIN
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• 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

Older Hydrated Versions#

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

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

Orange Book products#

Current product rows page 1 of 1 · 2 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 3 · 88 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Reported adverse events (FAERS/openFDA)#

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