OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution 
Dr. Reddy's Laboratories Inc.

----------

ACTIVE INGREDIENT

Olopatadine (0.2%)  (equivalent to olopatadine hydrochloride 0.222%)

PURPOSE

Antihistamine

USE

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

WARNINGS

For external use only

DO NOT USE

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

you experience:  

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

OTHER INFORMATION

• only for use in the eye  
• store between 2° to 25°C (36° to 77°F)

INACTIVE INGREDIENTS

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Edetate disodium, Hydrochloric acid/Sodium hydroxide (adjust pH), Povidone, Sodium chloride, and Water for Injection.

QUESTIONS?

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

NDC 68083-231-01
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Bottle Label:
Bottle
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Carton Label:















Carton
OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-764(NDC:68083-231)
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)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-764-021 in 1 CARTON09/01/2020
12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:43598-764-252 in 1 CARTON09/01/2020
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
ANDAANDA20975209/01/2020
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 11/2023
Document Id: 39e1386c-3328-1883-f690-ed3adb16da41
Set id: f249d79e-0f62-d2f1-bcbc-22dda253aad2
Version: 3
Effective Time: 20231105
 
Dr. Reddy's Laboratories Inc.