Eye itch relief solution/ drops

Spl unclassified section

Drug Facts

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

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

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • 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 eye
  • itching worsens or lasts 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 of age and older:Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age:Consult a doctor.

Other information

  • only for use in the eye
  • store at 20 to 25C (68 to 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?

1-800-932-5676

Ingredients and appearance - Product information

Eye itch relief solution/ drops- Ketotifen fumarate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68016-403
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Ketotifen fumarate ( UNII: HBD503WORO)( Ketotifen - UNII: X49220T18G ) 0.35 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Benzalkonium chloride ( UNII: F5UM2KM3W7)
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 - Chain Drug Consortium( 101668460)

Establishment

Name ID/FEI Business Operations
Chain Drug Consortium 101668460 MANUFACTURE( 68016-403), ANALYSIS( 68016-403), STERILIZE( 68016-403), PACK( 68016-403), LABEL( 68016-403)

Package label.principal display panel

Principal Display Panel Text for Container Label:

NDC 68016-403-00

Premier

Value ®Logo

Eye Itch Relief

ANTIHISTAMINE

EYE DROPS

Ketotifen Fumarate

Ophthalmic Solution

5 mL (0.17 FL OZ)

STERILE

Package label.principal display panel

Principal Display Panel Text for Carton Label:

NDC 68016-403-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN ZADITOR ®

Premier

Value ®Logo

Eye Itch

Relief

ANTIHISTAMINE

EYE DROPS

Ketotifen Fumarate

Ophthalmic Solution

  • Works in minutes
  • Original prescription strength
  • For ages 3 years & older
  • 30-day supply

UP TO

12

HOURS

ITCH RELIEF

5 mL (0.17 FL OZ)

STERILE PV Brand Logo