eye itch relief

eye itch relief
SPL v5
SPL
SPL Set ID b25106f8-436e-4c06-8780-b12368ede9fe
Route
ophthalmic
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
nda active Since 2014-01-02

Purpose

Antihistamine

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)


Medication Information

Warnings

For external use only

Do not use

  • if you are sensitive to any ingredient in this product
  • if solution changes color or becomes cloudy
  • to treat contact lens related irritation

When using this product

  • remove contact lenses before use
  • wait at least 10 minutes before re-inserting contact lenses after use
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor ifyou experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that worsens or lasts for more than 72 hours
Uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Purpose

Antihistamine

Directions
  • adults and children 3 years and older:
  • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • children under 3 years of age:consult a doctor

Other Information

store at 4—25 °C (39—77 °F)

Inactive Ingredients

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

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Active Ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

Questions Or Comments?

[phone icon] Call : 1-800-910-6874

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

NDC 11673-064-05

Compare to Systane

ZADITOR active ingredient*

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

For Ages 3 Years and Older

• Original prescription strength

• 30-day supply

• Works in minutes

[arrow icon] up & up™ Up To

12

Hours

For Ages 3 years

and Older

STERILE 0.17 FL OZ (5 mL)


Structured Label Content

Warnings

For external use only

Do not use

  • if you are sensitive to any ingredient in this product
  • if solution changes color or becomes cloudy
  • to treat contact lens related irritation

When using this product

  • remove contact lenses before use
  • wait at least 10 minutes before re-inserting contact lenses after use
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor ifyou experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that worsens or lasts for more than 72 hours
Uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Purpose

Antihistamine

Directions
  • adults and children 3 years and older:
  • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • children under 3 years of age:consult a doctor

Other Information (Other information)

store at 4—25 °C (39—77 °F)

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (Active ingredient)

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

Questions Or Comments? (Questions or comments?)

[phone icon] Call : 1-800-910-6874

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 11673-064-05

Compare to Systane

ZADITOR active ingredient*

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

For Ages 3 Years and Older

• Original prescription strength

• 30-day supply

• Works in minutes

[arrow icon] up & up™ Up To

12

Hours

For Ages 3 years

and Older

STERILE 0.17 FL OZ (5 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)