OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution 
Retail Business Services, LLC.

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Drug Facts

Active ingredient
Olopatadine (0.1%).
(equivalent to olopatadine hydrochloride, USP 0.111%)

Purpose

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

When using this product

Stop use and ask a doctor if you experience:

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

    consult a doctor

Other information

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride and water for injection

Questions?

✆1-855-274-4122

Distributed by:
FOODHOLD U.S.A., LLC,
LANDOVER, MD 20785
MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

CAREOne                 NDC 72476-852-64
EYE ALLERGY ITCH
& REDNESS RELIEF
Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
STERILE            5 mL (0.17 FL OZ)
olopatadine-figure-1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

CAREOne          NDC 72476-852-64
Compare to the Active Ingredient in
Pataday® Twice Daily Relief®
EYE ALLERGY ITCH
& REDNESS RELIEF

Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.1%
TWICE DAILY
Now available without a prescription
Antihistamine and Redness Reliver
Works in Minutes
Relief from Allergens:
Pet Dander, Pollen, Grass, Ragweed
                                          STERILE
                                          5 mL (0.17 FL OZ)
olopatadine-figure-2

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-852
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, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-852-641 in 1 CARTON05/06/2021
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20481205/06/2021
Labeler - Retail Business Services, LLC. (967989935)
Registrant - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650498244ANALYSIS(72476-852) , MANUFACTURE(72476-852)

Revised: 5/2021
Document Id: 3de497ac-ef3e-4eb0-88e3-723394770274
Set id: bd2deb79-c135-2d3f-e053-2a95a90a9322
Version: 2
Effective Time: 20210507
 
Retail Business Services, LLC.