OLOPATADINE- olopatadine hydrochloride solution/ drops

Olopatadine by

Drug Labeling and Warnings

Olopatadine by is a Otc medication manufactured, distributed, or labeled by Akorn, Inc., AKORN OPERATING COMPANY LLC, Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)

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 the 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
• do not wear a contact lens if your eye is red

Stop use and ask a doctor if you experience:

• eye pain
• changes in vision
• increased 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.

Directions

• adults and children 2 years of age and older:
  • put 1 drop in the affected eye(s) once daily, no more than once per day
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • replace cap after each use
• children under 2 years of age: consult a doctor

Other information

• only for use in the eye
• store at 4° to 25°C (39° to 77°F).

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride, and water for injection

Questions?

Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-312-12

Olopatadine HCl Ophthalmic

Solution, USP 0.2%

Antihistamine

ONCE DAILY

STERILE 2.5 mL (0.085 FL OZ)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Original NDC: 17478-312-12

Prescription

Strength Akorn logo

Olopatadine

HCl Ophthalmic

Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

Pet Dander

Pollen

Grass

Ragweed

ONCE DAILY

STERILE

2.5 mL (0.085 FL OZ)

INGREDIENTS AND APPEARANCE

OLOPATADINE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17478-312
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM)	Olopatadine	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
sodium phosphate, dibasic, unspecified form (UNII: GR686LBA74)
edetate disodium (UNII: 7FLD91C86K)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)
povidone, unspecified (UNII: FZ989GH94E)
sodium chloride (UNII: 451W47IQ8X)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-312-12	1 in 1 CARTON	09/01/2021
1		2.5 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	ANDA204723	09/01/2021

OLOPATADINE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17478-305
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM)	Olopatadine	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
sodium phosphate, dibasic, unspecified form (UNII: GR686LBA74)
edetate disodium (UNII: 7FLD91C86K)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)
povidone, unspecified (UNII: FZ989GH94E)
sodium chloride (UNII: 451W47IQ8X)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-305-11	2 in 1 CARTON	09/01/2021
1		2.5 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	ANDA204723	09/01/2021

Labeler - Akorn (117696770)

Registrant - AKORN OPERATING COMPANY LLC (117693100)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn		117696840	LABEL(17478-312, 17478-305) , MANUFACTURE(17478-312, 17478-305) , PACK(17478-312, 17478-305) , ANALYSIS(17478-312, 17478-305) , STERILIZE(17478-312, 17478-305)