Eye itch relief solution

Active ingredient

Ketotifen 0.025%

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Uses

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

Warningsfor 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

Keep out of reach of children.

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

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.

Children under 3 years of age:consult a doctor

Other information

Store at 4-25C (39-77F)

Inactive ingredients

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

Questions?

Call: 1-800-553-5340

*This product is not manufactured or distributed by Novartis, distributor of Zaditor.

Ingredients and appearance - Product information

Eye itch relief solution- Ketotifen fumarate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 21130-601
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Ketotifen fumarate ( UNII: HBD503WORO)( Ketotifen - UNII: X49220T18G ) 0.25 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Benzalkonium chloride ( UNII: F5UM2KM3W7)
Glycerin ( UNII: PDC6A3C0OX)
Hydrochloric acid ( UNII: QTT17582CB)
Sodium hydroxide ( UNII: 55X04QC32I)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021996 USA

Labeler - Safeway( 009137209)

Establishment

Name ID/FEI Business Operations
Safeway 009137209 MANUFACTURE( 21130-601)

Package/label principal display panel 5ml carton

NDC 21130-601-05

Signature™
Care

Quality Guaranteed

STERILE
ORIGINAL PRESCRIPTON STRENGTH

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
Antihistamine Eye Drops

Compare to the active ingredient in Zaditor*

Up to 12 hours


0.17 FL OZ (5mL)