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Itchy Eye by Kroger Company

Medically reviewed on January 22, 2018

Dosage form: solution/ drops
Ingredients: ketotifen fumarate 0.35mg in 1mL
Labeler: Kroger Company
NDC Code: 30142-770

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. (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?

1-800-632-6900

Principal Display Panel Text for Container Label:

NDC 30142-770-01

Kroger Logo®

STERILE

Itchy Eye Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label:

COMPARE TO the active ingredient of

Zyrtec® *See side panel

NDC 30142-770-01

Kroger Logo®

FROM OUR FAMILY
TO YOURS

ORIGINAL PRESCRIPTION STRENGTH

STERILE

Itchy Eye

Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

  • Works in Minutes
  • For Ages 3 Years
    & Older
  • 30 Day Supply

LASTS UP TO
12

HOURS

5 mL

(0.17 FL OZ)

ITCHY EYE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-770
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:30142-770-011 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/22/2014
Labeler - Kroger Company (006999528)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(30142-770), ANALYSIS(30142-770), STERILIZE(30142-770), PACK(30142-770), LABEL(30142-770)

 
Kroger Company

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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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