OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION - olopatadine hydrochloride ophthalmic solution 
Gland Pharma Limited

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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?

contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRINCIPAL DISPLAY PANEL

NDC 68083-231-01
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Bottle Label:
olopatadine-spl-bottle
 
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
C
arton Label:
olopatadine-SPL-carton
 














 

OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
olopatadine hydrochloride ophthalmic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:68083-231-011 in 1 CARTON05/20/2020
12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20975205/20/2020
Labeler - Gland Pharma Limited (918601238)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238ANALYSIS(68083-231) , MANUFACTURE(68083-231) , PACK(68083-231)

Revised: 5/2020
Document Id: 9a4c58dc-aee6-441f-8081-608e4fd36193
Set id: 9a4c58dc-aee6-441f-8081-608e4fd36193
Version: 1
Effective Time: 20200523
 
Gland Pharma Limited