drug facts

drug facts
SPL v8
SPL
SPL Set ID 9ce8f926-c202-40d1-9dba-0477f1f49e14
Route
ophthalmic
Published
Effective Date 2024-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ketotifen (0.35 mg)
Inactive Ingredients
benzalkonium chloride glycerin hydrochloric acid sodium hydroxide water

Identifiers & Packaging

Marketing Status
nda active Since 2013-09-03

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 content 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: 1-800-459-6906

Distributed by: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com

© 2023 Walgreen Co. PRODUCT OF ITALY

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

VALUE SIZE

NDC 0363-0038-10

Walgreens

Compare to Systane ZADITOR active ingredient ††

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Up to 12 Hours

  • Original prescription strength
  • Works in minutes
  • 60 day supply
  • For ages 3
  • years and older
  • STERILE 0.34 FL OZ (10 mL)
  • 9756201

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 content 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: 1-800-459-6906

Distributed by: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com

© 2023 Walgreen Co. PRODUCT OF ITALY

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)

VALUE SIZE

NDC 0363-0038-10

Walgreens

Compare to Systane ZADITOR active ingredient ††

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Up to 12 Hours

  • Original prescription strength
  • Works in minutes
  • 60 day supply
  • For ages 3
  • years and older
  • STERILE 0.34 FL OZ (10 mL)
  • 9756201

Advanced Ingredient Data


Raw Label Data

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