ALLERGY EYE DROPS- ketotifen fumarate solution/ drops

Allergy Eye Drops by

Drug Labeling and Warnings

Allergy Eye Drops by is a Otc medication manufactured, distributed, or labeled by Advanced Vision Research (Subsidiary of Akorn, Inc.), Akorn, Inc., Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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°-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?

1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

CVS

pharmacy®

NDC: 58790-301-02

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

pharmacy®

NDC: 58790-301-02

Compare to the

active ingredient

in Alaway®*

NEW!

Contains the drug

Ketotifen Fumarate

ALLERGY

EYE DROPS

KETOTIFEN FUMARATE

OPHTHALMIC SOLUTION

ANTIHISTAMINE

EYE DROPS

Works in minutes

• Original prescription strength
• For ages 3 years & older
• Relief for itchy eyes
• 60-day supply

up to

12

HOURS

10 mL ITCH RELIEF

(0.34 FL OZ)

STERILE

INGREDIENTS AND APPEARANCE

ALLERGY EYE DROPS 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58790-301
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
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: 58790-301-02	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	11/14/2013

Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(58790-301) , ANALYSIS(58790-301) , STERILIZE(58790-301) , PACK(58790-301) , LABEL(58790-301)