Your browser does not support JavaScript! GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [DISPENSING SOLUTIONS, INC.]
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RxNorm Names

GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF (ketotifen fumarate) solution
[Dispensing Solutions, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68258-8900(NDC:24385-494)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68258-8900-55 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/13/2010
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785relabel(68258-8900), repack(68258-8900)

Revised: 7/2013
 
Dispensing Solutions, Inc.

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