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 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 8-12 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°C to 25°C (68°F 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?

1-800-579-8327

Principal Display Panel Text for Container Label:

Well at

Walgreens NDC 0363-9060-00

STERILE ● ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops 0.34 FL OZ (10 mL)

Principal Display Panel Text for Container Label:

Principal Display Panel Text for Carton Label:

Well at

Walgreens NDC 0363-9060-00

WALGREENS PHARMACIST RECOMMENDED≠

STERILE ● ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Works in minutes
For ages 3 years & older
60-day supply

HOUR

0.34 FL OZ (10 mL)

Principal Display Panel Text for Carton Label:

KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-9060
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ketotifen fumarate (Ketotifen)	Ketotifen	0.35 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride
glycerin
water
hydrochloric acid
sodium hydroxide

Packaging
#	Item Code	Package Description
1	NDC:0363-9060-00	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	01/25/2013

Labeler - Walgreens (008965063)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(0363-9060), ANALYSIS(0363-9060), STERILIZE(0363-9060), PACK(0363-9060), LABEL(0363-9060)