drug facts

drug facts
SPL v3
SPL
SPL Set ID b723daa3-6c6f-4a96-a15d-0d5866f28ca4
Route
ophthalmic
Published
Effective Date 2023-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
nda active Since 2022-03-15

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 if you 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: 1-888-423-0139

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 36800-097-05

+Top Care

health

COMPARE TO Systane ZADITOR

active ingredient*

Eye Itch Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE

EYE DROPS UPTO

12

HOURS

  • Works in Minutes
  • Original Prescription Strength
  • For Ages 3 Years and Older

STERILE 0.17FL OZ (5 mL)

9756901

FT60107


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 if you 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: 1-888-423-0139

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 36800-097-05

+Top Care

health

COMPARE TO Systane ZADITOR

active ingredient*

Eye Itch Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE

EYE DROPS UPTO

12

HOURS

  • Works in Minutes
  • Original Prescription Strength
  • For Ages 3 Years and Older

STERILE 0.17FL OZ (5 mL)

9756901

FT60107


Advanced Ingredient Data


Raw Label Data

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