OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution 
GLENMARK THERAPEUTICS INC., USA

----------

Drug Facts

Active Ingredients

 
Purpose

Olopatadine 0.2%
(equivalent to olopatadine hydrochloride 0.222%)

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 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 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:
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?

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Product of Spain

07/2025

PRINCIPAL DISPLAY PANEL

NDC 72657-194-25

Olopatadine HCl Ophthalmic Solution 0.2% 

Antihistamine

Once Daily
STERILE

2.5 mL (0.085 FL OZ)

label

NDC: 72657-194-25

Original Prescription Strength

ONCE DAILY

Olopatadine HCl Ophthalmic Solution, USP 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL (0.085 FL OZ)

carton
OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-194
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-194-251 in 1 CARTON02/28/2025
12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:72657-194-112 in 1 CARTON02/28/2025
22.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21955702/28/2025
Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
Establishment
NameAddressID/FEIBusiness Operations
SamChunDang Pharm Co, Ltd687792325MANUFACTURE(72657-194)

Revised: 1/2026
Document Id: 5ce14b14-b893-4d56-a19e-b1788b17074f
Set id: 07e8b359-d4ae-4b5b-81dc-c7e57e172c58
Version: 3
Effective Time: 20260127
 
GLENMARK THERAPEUTICS INC., USA