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 STRATEGIC SOURCING SERVICES LLC, Akorn Operating Company LLC, Akorn, Akorn AG, Hi-Tech Pharmacal Co. Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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?

1-800-923-5676

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

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Sunmark Logo®

NDC: 49348-107-17

sterile

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Sunmark Logo®

COMPARE TO ZADITOR®

ACTIVE INGREDIENT*

NDC: 49348-107-17

sterile

eye itch

relief

ketotifen fumarate

ophthalmic

solution 0.035%

Antihistamine Eye Drops

For ages 3 years and older

30-day supply

Works in minutes

Original Prescription Strength

UP TO 12 HOURS OF RELIEF

5 mL (0.17 FL OZ)

INGREDIENTS AND APPEARANCE

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-107
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: 49348-107-17	1 in 1 CARTON	02/07/2014
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	02/07/2014

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(49348-107) , ANALYSIS(49348-107) , STERILIZE(49348-107) , PACK(49348-107) , LABEL(49348-107)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	MANUFACTURE(49348-107)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co. Inc.		101196749	LABEL(49348-107) , PACK(49348-107)