Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 0fe119ad-cb44-4e90-a096-0ed0ba63dc31
Route
OPHTHALMIC
Published
Effective Date 2025-11-20
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 2021-10-15
Description

Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Purpose Antihistamine Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander. Warnings For external use only 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 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. 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. Questions? Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number. Made in India Distributed by: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816 USA Rev. 11/2025 KFO1236

Medication Information

Description

Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Purpose Antihistamine Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander. Warnings For external use only 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 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. 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. Questions? Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number. Made in India Distributed by: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816 USA Rev. 11/2025 KFO1236

Section 42229-5

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

Warnings

For external use only

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

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.

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.

Questions?

Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number.

Made in India

Distributed by:

UNICHEM PHARMACEUTICALS (USA), INC.

East Brunswick, NJ 08816 USA

Rev. 11/2025

KFO1236

Package Label.principal Display Panel

NDC 76385-106-17

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ)

Sterile

Structured Label Content

Section 42229-5 (42229-5)

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

Warnings

For external use only

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

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.

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.

Questions?

Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number.

Made in India

Distributed by:

UNICHEM PHARMACEUTICALS (USA), INC.

East Brunswick, NJ 08816 USA

Rev. 11/2025

KFO1236

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 76385-106-17

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ)

Sterile

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:19.708487 · Updated: 2026-03-14T23:10:38.535907