OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution 
Aurohealth LLC

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Drug Facts

Active ingredient
Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride, USP 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 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, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection

Questions?

✆1-855-274-4122

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

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

AUROHEALTH          NDC 58602-007-39
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Antihistamine
Eye Allergy Itch Relief
STERILE                2.5 mL (0.085 FL OZ)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

AUROHEALTH             NDC 58602-007-39
                 *Compare to the Active Ingredient in
                        Pataday® Once Daily Relief
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Antihistamine
Eye Allergy Itch Relief
Works in Minutes
Relief from Allergens:                    ONCE
• Pet Dander • Pollen                    DAILY
• Grass • Ragweed                      STERILE
                                 2.5 mL (0.085 FL OZ)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack

Twin Pack
AUROHEALTH             NDC
58602-007-41
                  *Compare to the Active Ingredient in
                              Pataday® Once Daily Relief
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Antihistamine
Eye Allergy Itch Relief
Works in Minutes
Relief from Allergens:                    ONCE
• Pet Dander • Pollen                    DAILY
• Grass • Ragweed                      STERILE
                                    Two 2.5 mL Bottles
                                    (0.085 FL OZ Each)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-007
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-007-391 in 1 CARTON07/15/2020
12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:58602-007-412 in 1 CARTON07/15/2020
22.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20999507/15/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Eugia Pharma Specialities Limited650498244ANALYSIS(58602-007) , MANUFACTURE(58602-007)

Revised: 5/2022
Document Id: 56afd9f1-e262-4e17-8e68-0ef767cd4338
Set id: b022f8f9-ad3d-4a6d-96aa-24c1ccd1f422
Version: 5
Effective Time: 20220507
 
Aurohealth LLC