CARE ONE EYE ITCH RELIEF - ketotifen fumarate solution 
American Sales Company

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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 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

Other information

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

Package/Label Principal Display Panel

Compare to active ingredient in Zaditor®

EYE ITCH RELIEF

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

UP TO 12 HOURS

For Ages 3 Years & Older

30 Day Supply

Sterile

Eye Itch Relief Carton Image 1

Eye Itch Relief Carton Image 1

Eye Itch Relief Carton Image 2

Eye Itch Relief Carton Image 2


CARE ONE EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-923
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN FUMARATE0.25 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:41520-923-011 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
15 mL in 1 BOTTLEThis package is contained within the CARTON (41520-923-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795808/30/2010

Labeler - American Sales Company (809183973)

Revised: 12/2011 American Sales Company