OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution 
Aurohealth 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?

✆1-855-274-44122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
Code: TS/DRUGS/13/2010

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

PrimaryHealth                             NDC 58602-012-40
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
STERILE                                     5 mL (0.17 FL OZ)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

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

                                                      NDC 58602-012-40
                                                            PrimaryHealth
                              *Compare to the Active Ingredient
                                     in Pataday® Once Daily Relief
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen                     TWICE
• Grass • Ragweed                          DAILY
                                                     STERILE
                                      5 mL (0.17 FL OZ)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-012
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:58602-012-401 in 1 CARTON07/15/2020
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20481207/15/2020
Labeler - Aurohealth LLC (078728447)
Registrant - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650498244ANALYSIS(58602-012) , MANUFACTURE(58602-012)

Revised: 8/2020
Document Id: 8fb16daa-340d-45a0-ab22-e028d77e2476
Set id: 8fb16daa-340d-45a0-ab22-e028d77e2476
Version: 1
Effective Time: 20200821
 
Aurohealth LLC