drug facts

drug facts
SPL v2
SPL
SPL Set ID 5196ec5b-42d9-40db-a77a-c00360b8cee6
Route
ophthalmic
Published
Effective Date 2025-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ketotifen (0.25 mg)
Inactive Ingredients
glycerin sodium hydroxide hydrochloric acid benzalkonium chloride

Identifiers & Packaging

Marketing Status
anda active Since 2024-07-12

Purpose

Antihistamine

Description

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


Medication Information

Warnings

For external use only

Purpose

Antihistamine

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

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

Description

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

Questions?

Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.

Code No.: GO/DRUGS/557

Manufactured For:

Bayshore Pharmaceuticals

LLC., Short Hills, NJ 07078

Made in India.

Relabeled By: Preferred Pharmaceuticals Inc.

Use

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

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%)

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
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
Keep Out of Reach of Children.

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

Principal Display Panel Bottle Carton

NDC 68788-8715-5

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

5 mL (0.17 FL OZ)

Sterile


Structured Label Content

Warnings

For external use only

Purpose

Antihistamine

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

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

Questions?

Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.

Code No.: GO/DRUGS/557

Manufactured For:

Bayshore Pharmaceuticals

LLC., Short Hills, NJ 07078

Made in India.

Relabeled By: Preferred Pharmaceuticals Inc.

Use

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

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%)

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
Stop Use and Ask A Doctor If (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
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.

Principal Display Panel Bottle Carton (Principal Display Panel - Bottle Carton)

NDC 68788-8715-5

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

5 mL (0.17 FL OZ)

Sterile


Advanced Ingredient Data


Raw Label Data

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