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Itchy Eye Relief

Western Family Foods Inc

Western Family Itchy Eye Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Antihistamine

Itchy Eye Relief 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

  • 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.

  • Children under 3 years of age:

Consult a doctor.

Itchy Eye Relief Other information

  • only for use in the eye
  • store at 20-25°C (68-77°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?

1-800-719-9260

Package/Label Principal Display Panel

Itchy Eye RELIEF

Ketotifen Fumarate Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

ORIGINAL PRESCRIPTION STRENGTH

UP TO 12 HOURS

Allergy Itchy Eye Relief

WORKS IN MINUTES

FOR AGES 3 YRS. & OLDER

30 DAY SUPPLY

STERILE

COMPARE TO THE ACTIVE INGREDIENT OF ZYRTEC® ITCHY EYE DROPS

Itchy Eye Relief
Itchy Eye Relief Carton Image 1 Itchy Eye Relief Carton Image 2

Itchy Eye Relief

Ketotifen SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-615
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ketotifen Fumarate Ketotifen 0.25 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE
2 NDC:55312-615-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 2011-05-25


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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