Itchy eye solution

Active ingredient

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

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

  1. if solution changes color or becomes cloudy
  2. if you are sensitive to any ingredient in this product
  3. to treat contact lens related irritation

When using this product

  1. do not touch tip of container to any surface to avoid contamination
  2. remove contact lenses before use
  3. wait at least 10 minutes before reinserting contact lenses after use
  4. replace cap after each use

Stop use and ask a doctor if you experience any of the following:

  1. eye pain
  2. changes in vision
  3. redness of the eye
  4. itching 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. (1-800-222-1222)

Directions

  1. Adults and children 3 years of age and older:

Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

  1. Children under 3 years of age:

Consult a doctor.

Other information

  1. only for use in the eye
  2. store at 20-25C (68-77F) [see USP Controlled Room Temperature]

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Itchy eye solution- Ketotifen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0904-5837
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
Glycerin ( UNII: PDC6A3C0OX)
Water ( UNII: 059QF0KO0R)
Hydrochloric acid ( UNII: QTT17582CB)
Sodium hydroxide ( UNII: 55X04QC32I)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077958 USA

Labeler - Major Pharmaceuticals( 191427277)

Package/label principal display panel

Compare to active ingredient of Zyrtec® Itchy Eye Drops

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

UP TO 12 HOURS

ALLERGY ITCHY EYE RELIEF

WORKS IN MINUTES

For Ages 3 Yrs. & Older

30 Day Supply

Original Prescription Strength

Sterile

Itchy Eye Drops Carton Image 1 Itchy Eye Drops Carton Image 1

Itchy Eye Drops Carton Image 2