Eye Itch Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Eye Itch Relief

Amerisource Bergen
Akorn, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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 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?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 46122-163-64

GOOD NEIGHBOR PHARMACY Logo® Sterile

Eye Itch Relief

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

0.17 fl oz (5 mL)

Principal Display Panel Text for Carton Label:

NDC 46122-163-64

Compare to

Zaditor®

active ingredient*

GOOD NEIGHBOR PHARMACY Logo®

► 30 DAY SUPPLY

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

Up to 12 hours

Works in minutes

Original Prescription Strength

For ages 3 years and older

Sterile

0.17 fl oz

(5 mL)

Eye Itch Relief

ketotifen fumarate SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:46122-163
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ketotifen Fumarate Ketotifen 0.35 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
GLYCERIN
water
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE, DROPPER
2 NDC:46122-163-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 2013-12-06


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Be sure to consult your doctor before taking any medication!
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