GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF- ketotifen fumarate solution 
Dispensing Solutions, Inc.

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Amerisource Bergen Eye Itch Relief Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

. If solution changes color or becomes cloudyi

. 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.

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

NDC 68258-8900-05

NDC 68258-8900-05

GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-8900(NDC:24385-494)
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68258-8900-5 5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 11/13/2010
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 relabel(68258-8900) , repack(68258-8900)

Revised: 7/2013
Document Id: 02ad0855-49aa-44a6-80ef-e8a0be13eec2
Set id: e110e5fc-f853-4711-8134-515c7577775d
Version: 7
Effective Time: 20130718
 
Dispensing Solutions, Inc.