drug facts

drug facts
SPL v3
SPL
SPL Set ID d3049296-0d15-4523-883c-25f8817bc735
Route
ophthalmic
Published
Effective Date 2024-04-01
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 2024-04-01

Purpose

Antihistamine

Description

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

Active Ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

Questions Or Comments?

[Phone icon] Call: 1-833-354-4500

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
Keep Out of Reach of Children.

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

Package/label Principal Display Panel

GOODSENSE ® NDC 50804-601-05

For ages 3 years and older

Eye Itch Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Up to 12hours

works in minutes

Original Prescription Strength

Compare to active ingredient of

Systane ZADITOR*

STERILE 0.17 FL OZ (5 ml)

9797500

MH60107

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

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
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 fumerate 0.035%)

Questions Or Comments? (Questions or comments?)

[Phone icon] Call: 1-833-354-4500

When Using This Product (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
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)

GOODSENSE ® NDC 50804-601-05

For ages 3 years and older

Eye Itch Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Up to 12hours

works in minutes

Original Prescription Strength

Compare to active ingredient of

Systane ZADITOR*

STERILE 0.17 FL OZ (5 ml)

9797500

MH60107

Stop Use and Ask A Doctor If You Experience Any of the Following: (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

Advanced Ingredient Data


Raw Label Data

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