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

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ACTIVE INGREDIENT(S)

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

PURPOSE

Antihistamine and redness reliever

USE(S)

temporarily relieves itchy 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 DOCTOR IF

you experience:


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/sodium hydroxide (adjust pH), sodium chloride, and water for Injection

QUESTIONS?

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

PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label:

olopatadine-container

 Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label:

olopatadine-carton

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62332-709
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62332-709-051 in 1 CARTON02/18/2021
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20991902/18/2021
Labeler - Alembic Pharmaceuticals Inc. (079288842)
Establishment
NameAddressID/FEIBusiness Operations
Gland Pharma Limited918601238MANUFACTURE(62332-709)

Revised: 2/2021
Document Id: 3b330307-f5b5-473f-a4dd-56a080a1b518
Set id: bd1f9779-d048-46ff-a570-ce3ad92715e7
Version: 3
Effective Time: 20210219
 
Alembic Pharmaceuticals Inc.