OLOPATADINE HYDROCHLORIDE solution/ drops

Olopatadine Hydrochloride by

Drug Labeling and Warnings

Olopatadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Alembic Pharmaceuticals Inc., Gland Pharma Limited, Alembic Pharmaceuticals Limited (F3). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Olopatadine 0.2%................ (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

Antihistamine

USE(S)

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

STOP USE AND ASK 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 between 2°C to 25°C (36°F to 77°F)

INACTIVE INGREDIENT SECTION

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

QUESTIONS?

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - GLAND

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - GLAND

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - ALEMBIC 

 

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - ALEMBIC

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62332-710
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62332-710-03	1 in 1 CARTON	01/25/2021
1		2.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209420	01/25/2021

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	MANUFACTURE(62332-710)

Establishment
Name	Address	ID/FEI	Business Operations
Alembic Pharmaceuticals Limited (F3)		675480734	MANUFACTURE(62332-710)