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 (0.1%).........(equivalent to olopatadine hydrochloride 0.111%)

PURPOSE

Antihistamine and redness reliever

USE(S)

temporarily relieves itchy red 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) twice daily, every 6 to 8 hours, no more than twice 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 4°C to 25°C (39°F to 77°F)

INACTIVE INGREDIENTS

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

QUESTIONS?

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

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Gland

 

Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Alembic 

 Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Gland

 

Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Alembic

 

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62332-709
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62332-709-05	1 in 1 CARTON	02/18/2021
1		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	ANDA209919	02/18/2021

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	MANUFACTURE(62332-709)

Establishment
Name	Address	ID/FEI	Business Operations
Alembic Pharmaceuticals Limited (F3)		675480734	MANUFACTURE(62332-709)