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

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Drug Facts

Active Ingredient

Purpose

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

Antihistamine and redness reliever

Uses

temporarily relieves itchy and 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 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) 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 and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.

Questions or comments?

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

07/25

PRINCIPAL DISPLAY PANEL

NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief

STERILE

5 mL (0.17 FL OZ)

carton


NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution,USP 0.1%

Antihistamine and Redness Reliever

Twice Daily


STERILE
5 mL (0.17 FL OZ)

label
OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride ophthalmic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-168
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
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:72657-168-501 in 1 CARTON07/26/2024
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20081007/26/2024
Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
Establishment
NameAddressID/FEIBusiness Operations
SamChunDang Pharm Co, Ltd687792325MANUFACTURE(72657-168)

Revised: 1/2026
Document Id: bc82a9d3-2fd3-4a7d-9126-c0f07a610b05
Set id: a80c3fd2-47b7-4ed0-b862-9c5099684607
Version: 3
Effective Time: 20260127
 
GLENMARK THERAPEUTICS INC., USA