OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution 
TOPCO ASSOCIATES 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:
TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO ARHA0323
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com
PRODUCT OF INDIA

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


+ Top Care®      NDC 76162-044-39
health             ONCE DAILY
Eye Allergy Itch Relief
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%
Antihistamine
STERILE      0.085 FL OZ (2.5 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

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


+ TopCare®           NDC 76162-044-39
      health
COMPARE TO PATADAY® ONCE DAILY
RELIEF ACTIVE INGREDIENT*
Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.2%
Eye Allergy
Itch Relief
Antihistamine
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed
                                                 ONCE
                                                DAILY
STERILE             0.085 FL (2.5 mL)


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

OLOPATADINE HYDROCHLORIDE 
olopatadine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-044
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:76162-044-391 in 1 CARTON07/15/2020
12.5 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 - TOPCO ASSOCIATES LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
EUGIA PHARMA SPECIALITIES LIMITED650498244ANALYSIS(76162-044) , MANUFACTURE(76162-044) , PACK(76162-044)

Revised: 6/2024
Document Id: 4dcb6552-c458-40c0-80f9-78ca2c668dfa
Set id: 1932ee68-43a5-6474-e063-6294a90aacaf
Version: 2
Effective Time: 20240614
 
TOPCO ASSOCIATES LLC