SPL v3
SPL
SPL Set ID 3a9e70ab-d188-488c-8c47-a2184eb4ef2c
Route
OPHTHALMIC
Published
Effective Date 2018-12-01
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 2007-10-01
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 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 for more than 72 hours
Section 51945-4

Principal Display Panel Text for Carton Label:

Now OTC! NDC 71205-115-05

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

Directions
  • •
    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.
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
Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

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

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 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 for more than 72 hours
Section 51945-4 (51945-4)

Principal Display Panel Text for Carton Label:

Now OTC! NDC 71205-115-05

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

Purpose

Antihistamine

Directions
  • •
    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.
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
Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:55.727407 · Updated: 2026-03-14T22:55:43.865902