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eye itch relief by McKesson Corp.

Medically reviewed on Feb 7, 2018

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: McKesson Corp.
NDC Code: 62011-0232

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:

Health Mart

PHARMACY Logo

NDC 62011-0232-1

eye itch relief

ketotifen fumarate

ophthalmic solution

antihistamine eye drops

sterile

0.17 FL OZ (5 mL)

Principal Display Panel Text for Carton Label:

NDC 62011-0232-1

Health Mart

PHARMACY Logo

compare to Zaditor® active ingredient*

for ages 3 years and older

eye itch relief

ketotifen fumarate

ophthalmic solution

antihistamine eye drops

original prescription strength

works in minutes

sterile

up to 12 hours

30 day supply

0.17 FL OZ (5 mL)

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0232
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (Ketotifen) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
glycerin 
water 
hydrochloric acid 
sodium hydroxide 
Packaging
#Item CodePackage Description
1NDC:62011-0232-11 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795802/07/2014
Labeler - McKesson Corp. (177667227)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(62011-0232), ANALYSIS(62011-0232), STERILIZE(62011-0232), PACK(62011-0232), LABEL(62011-0232)

 
McKesson Corp.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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