OLOPATADINE HYDROCHLORIDE solution

OLOPATADINE HYDROCHLORIDE by

Drug Labeling and Warnings

OLOPATADINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, SamChunDang Pharm Co, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients:
  • Purpose
• Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%):

  Antihistamine

INDICATIONS & USAGE

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

WARNINGS

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

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

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:
  • o put 1 drop in the affected eye(s) once daily, no more than once per day
  • o if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    
  • o 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 ingredients

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

Questions?

In the U.S., call toll free weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

March 2025

PRINCIPAL DISPLAY PANEL

Olopatadine hydrochloride 
ophthalmic solution 0.2% 

Antihistamine
2.5 mL
STERILE

EYE ALLERGY ITCH RELIEF

Original Prescription Strength

ONCE DAILY RELIEF

Olopatadine hydrochloride ophthalmic solution 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL

NDC: 72657-194-25

INGREDIENTS AND APPEARANCE

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72657-194
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72657-194-25	1 in 1 CARTON	02/28/2025
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 72657-194-11	2 in 1 CARTON	02/28/2025
2		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA219557	02/28/2025

Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)

Establishment
Name	Address	ID/FEI	Business Operations
SamChunDang Pharm Co, Ltd		687792325	MANUFACTURE(72657-194)