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itchy eye

H E B

HEB Itchy Eye Drops Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Antihistamine

itchy eye 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 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

COMPARE TO ZYRTEC® ITCHY EYE DROPS active ingredient

Itchy Eye Drops

Ketotifen Fumarate Opthalmic Solution

Antihistamine Eye Drops

ALLERGY ITCHY EYE RELIEF

Up To 12 Hours

WORKS IN MINUTES

ORIGINAL PRESCRIPTION STRENGTH

For Ages 3 Years & Older

30 Day Supply

STERILE

itchy eye
Itchy Eye Drops Carton Image 1 Itchy Eye Drops Carton Image 2

itchy eye

Ketotifen SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-615
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
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE
2 NDC:37808-615-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 2010-09-15


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Be sure to consult your doctor before taking any medication!
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