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 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 Text for Container Label

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)

Principal Display Panel Text for Carton Label

OLOPATADINE
olopatadine hydrochloride solution/ drops

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204723	09/01/2021

Labeler - Akorn (117696770)

Registrant - AKORN OPERATING COMPANY LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
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)

Drug Facts

Active ingredient

Purpose

Use

Warnings

Do not use

When using the product

Directions

Other information

Inactive ingredients

Questions?