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?

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

Distributed by:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

Product of Spain

May 2023

PRINCIPAL DISPLAY PANEL

NDC 72657-168-50

Olopatadine hydrochloride ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief

5 mL
STERILE

carton


NDC 72657-168-50

Olopatadine hydrochloride ophthalmic solution 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief



5 mL
STERILE

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: 7/2024
Document Id: 0de466c5-7659-431b-b0a7-2d64ded8d341
Set id: a80c3fd2-47b7-4ed0-b862-9c5099684607
Version: 2
Effective Time: 20240729
 
GLENMARK THERAPEUTICS INC., USA