Itchy Eye

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE 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

OTC - STOP USE SECTION

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 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• only for use in the eye
• store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.01%, Glycerin, Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 30142-770-01

Kroger Logo^®

STERILE

Itchy Eye Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

COMPARE TO the active ingredient of

Zyrtec^® *See side panel

NDC 30142-770-01

Kroger Logo^®

FROM OUR FAMILY
TO YOURS

ORIGINAL PRESCRIPTION STRENGTH

STERILE

Itchy Eye

Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

• Works in Minutes
• For Ages 3 Years
  & Older
• 30 Day Supply

LASTS UP TO
12

HOURS

5 mL

(0.17 FL OZ)

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

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

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

• Itchy Eye
• Ketotifen Fumarate
• Ketotifen
• benzalkonium chloride
• glycerin
• water
• hydrochloric acid
• sodium hydroxide

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

Inactive ingredient matches#

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Inactive ingredient links page 1 of 8 · 421 matching rows.

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#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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