EYE ITCH RELIEF- ketotifen fumarate solution/ drops

eye itch relief by

Drug Labeling and Warnings

eye itch relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Akorn Operating Company LLC, Akorn, Akorn AG. 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

For external use only

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 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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

Serious side effects associated with use of this product may be reported to this number

1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Rite Aid Pharmacy Logo®

ORIGINAL

PRESCRIPTION STRENGTH

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

5 mL (0.17 FL OZ) Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

TWIN PACK

Rite Aid Pharmacy Logo®

*Compare to the active ingredient of Zaditor®

ORIGINAL PRESCRIPTION STRENGTH

eye itch

relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

UP TO 12 HOURS ITCH RELIEF

works in minutes

for ages 3 years and older

60-day supply

            2
Sterile 1 – 5 mL

(0.17 FL OZ) BOTTLES

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-4202
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: 11822-4202-0	2 in 1 CARTON	12/06/2013
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	12/06/2013

Labeler - Rite Aid Corporation (014578892)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(11822-4202) , ANALYSIS(11822-4202) , STERILIZE(11822-4202) , PACK(11822-4202) , LABEL(11822-4202)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	MANUFACTURE(11822-4202)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co. Inc.		101196749	LABEL(11822-4202) , PACK(11822-4202)