ITCHY EYE- ketotifen fumarate solution/ drops 
Kroger Company

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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 Container Label

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)

Principal Display Panel Text for Carton Label
ITCHY EYE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-770
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
hydrochloric acid (UNII: QTT17582CB)  
sodium hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-770-011 in 1 CARTON01/22/201405/31/2018
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/22/201405/31/2018
Labeler - Kroger Company (006999528)

Revised: 10/2020
Document Id: 4245161e-482c-4cb8-b4ad-e67d7d8d4d2b
Set id: 5c112cc5-68ca-44e2-a526-d7c24ec67aa6
Version: 2
Effective Time: 20201021
 
Kroger Company