Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9
Route
OPHTHALMIC
Published
Effective Date 2021-03-23
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 2016-01-01

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Uses

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

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
Directions

Adults and children 3 years or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: consult a doctor

Active Ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package/label Principal Display Panel

NDC 49035-231-11

equate

Eye Itch

Relief

ketotifen fumarate


ophthalmic

solution 0.035%


ANTIHISTAMINE

EYE DROPS

  • Works in minutes
  • Original prescription strength
  • For ages 3 years and older
  • STERILE

UP TO 12 HOURS

2 x 10 mL BOTTLES

(0.34 FL OZ EACH)


Structured Label Content

Uses

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

Purpose

Antihistamine

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
Directions

Adults and children 3 years or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: consult a doctor

Active Ingredient (Active ingredient)

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

NDC 49035-231-11

equate

Eye Itch

Relief

ketotifen fumarate


ophthalmic

solution 0.035%


ANTIHISTAMINE

EYE DROPS

  • Works in minutes
  • Original prescription strength
  • For ages 3 years and older
  • STERILE

UP TO 12 HOURS

2 x 10 mL BOTTLES

(0.34 FL OZ EACH)


Advanced Ingredient Data


Raw Label Data

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