EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Good Sense

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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 25°C (68° to 77°F) [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?

1-866-696-0957

Principal Display Panel Text for Container Label:

NDC 50804-302-01

GOODSENSE® Logo

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

0.17 FL OZ (5 mL) Sterile

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 50804-302-01

GOODSENSE® Logo

Works in Minutes

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Up To 12 Hours Itch Relief

● For Ages 3 Years and Older

● 30 Day Supply

Original Prescription Strength

Compare to active ingredient of 100%

Zaditor®* SATISFACTION

GUARANTEED

0.17 FL OZ (5 mL) Sterile

Principal Display Panel Text for Carton Label
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-302
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-302-011 in 1 CARTON06/20/201401/31/2017
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795806/20/201401/31/2017
Labeler - Good Sense (076059836)

Revised: 10/2020
 
Good Sense