OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution 
TOPCO ASSOCIATES 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:
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-0.1% (5 mL Container)

+TopCare®             NDC 76162-020-40
       health                 TWICE DAILY
Eye Allergy Itch & Redness Relief
Olopatadine Hydrochloride Ophthalmic Solution USP,
0.1%
Antihistamine & Redness Reliever
STERILE            0.17 FL OZ (5 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

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

                                NDC 76162-020-40
+TopCare®
        health

COMPARE TO PATADAY® TWICE DAILY
          RELIEF ACTIVE INGREDIENT*

Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.1%
Eye Allergy Itch
& Redness Relief
Antihistamine & Redness Reliever
Works in Minutes                            
Relief from Allergens:                        
• Pet Dander • Pollen
• Grass • Ragweed
                                                          TWICE
                                                           DAILY
STERILE                       0.17 FL OZ (5 mL)


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:76162-020
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:76162-020-401 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 - TOPCO ASSOCIATES LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
EUGIA PHARMA SPECIALITIES LIMITED650498244ANALYSIS(76162-020) , MANUFACTURE(76162-020)

Revised: 6/2024
Document Id: a413aedd-c114-40a3-bfad-1f9db0565b0f
Set id: f5bddc73-1899-b5f0-e053-2995a90ab98f
Version: 2
Effective Time: 20240614
 
TOPCO ASSOCIATES LLC