OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution/ drops 
Alembic Pharmaceuticals Inc.

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ACTIVE INGREDIENT(S)

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


PURPOSE

Antihistamine

USE(S)

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:
• 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:

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 INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride, and water for Injection.

QUESTIONS?

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - GLAND

olopatadine-bottle

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - GLAND

olopatadine-carton

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - ALEMBIC 

olopatadine-bottle-alembic

 

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - ALEMBIC

olopatadine-carton-alembic

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62332-710
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62332-710-031 in 1 CARTON01/25/2021
12.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20942001/25/2021
Labeler - Alembic Pharmaceuticals Inc. (079288842)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238MANUFACTURE(62332-710)
Establishment
NameAddressID/FEIBusiness Operations
Alembic Pharmaceuticals Limited (F3)675480734MANUFACTURE(62332-710)

Revised: 10/2024
Document Id: b2029f57-947f-4e34-a1f4-d6a4e7d89046
Set id: 75823e5d-562a-43c2-8365-6f3f9484c9bf
Version: 2
Effective Time: 20241009
 
Alembic Pharmaceuticals Inc.