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

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Eye Itch Relief

H E B
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 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?

1-800-932-5676

Principal Display Panel Text for Container Label:

H ■ E ■ B Logo®

NDC 37808-802-01

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

STERILE 5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label:

NDC 37808-802-01 Compare to

the active

ingredients

in Zaditor®*

H ■ E ■ B Logo®

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Eye Drops

• Works in

Minutes

• Original

Prescription

Strength

• For ages

3 years

& Older

UP TO

12

HOURS

ITCH RELIEF

STERILE 5 mL (0.17 FL OZ)

Eye Itch Relief

Ketotifen Fumarate SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-802
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:37808-802-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 2014-02-25


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Be sure to consult your doctor before taking any medication!
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