Ketotifen Fumarate Solution/ Drops [Cvs Pharmacy] -

KETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]
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NDC	59779-330-02
Set ID	3057eccb-97ff-43c0-9669-ded7d50bc143
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number	ANDA077958

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Ketotifen (0.025%)
Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)
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.
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?

1-800-932-5676
PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

CVS Health™ Logo

NDC 59779-330-02

Allergy

Eye Drops

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

Antihistamine eye drops

10 mL (0.34 FL OZ) STERILE
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:

CVS Health™ Logo Compare to the active

ingredient in Alaway®*

NDC 59779-330-02

Original Prescription Strength

Allergy

Eye Drops

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

Antihistamine eye drops

GET UP TO

12

HOUR

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

10 mL (0.34 FL OZ)

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-330
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen	0.35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
benzalkonium chloride (UNII: F5UM2KM3W7)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59779-330-02	1 in 1 CARTON	10/11/2013
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077958	10/11/2013

Labeler - CVS Pharmacy (062312574)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn, Inc		117696840	MANUFACTURE(59779-330) , ANALYSIS(59779-330) , STERILIZE(59779-330) , PACK(59779-330) , LABEL(59779-330)

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Medic

KETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY]

Do not use

When using this product

Keep out of reach of children.

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