SPL v7
SPL
SPL Set ID 2f1f7540-8b6d-4c4f-b86d-4fd35a28f6be
Route
OPHTHALMIC
Published
Effective Date 2022-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketotifen (0.35 mg)
Inactive Ingredients
Benzalkonium Chloride Glycerin Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2014-02-07
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50566-9

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
Section 51945-4

Principal Display Panel Text for Container Label:

CVS Health™ Logo

Eye Itch Relief

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

0.035%

Antihistamine eye drops

STERILE

5 mL (0.17 FL OZ)

Warnings

For external use only

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.
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
Active Ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

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

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

Questions Or Comments?

1 -800-932-5676

Serious side effects associated with use of this product may be reported to this number

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
Keep Out of Reach of Children.

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

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

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
Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

CVS Health™ Logo

Eye Itch Relief

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

0.035%

Antihistamine eye drops

STERILE

5 mL (0.17 FL OZ)

Purpose

Antihistamine

Warnings

For external use only

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.
Do Not Use (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
Active Ingredient (Active ingredient)

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

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

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

Questions Or Comments? (Questions or comments?)

1 -800-932-5676

Serious side effects associated with use of this product may be reported to this number

When Using This Product (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.528169 · Updated: 2026-03-14T23:00:25.149305