OLOPATADINE HYDROCHLORIDE - olopatadine hydrochloride solution 
Allwell Health Inc

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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:
AllWell Health, Inc.
Princeton, NJ 08540
getallwell.com

Made in India

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

allwell        ONCE DAILY
eye allergy itch relief
olopatadine hydrochloride
ophthalmic solution USP, 0.2%
antihistamine
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)

                                         NDC 80539-001-39
allwell
eye allergy
itch relief
olopatadine hydrochloride
ophthalmic solution USP, 0.2%
original prescription strength
antihistamine
- works in minutes
relief from allergens:
- pollen - pet dander        ONCE
- grass  - ragweed            DAILY
2.5 mL (0.085 FL OZ)    STERILE
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:80539-001
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:80539-001-391 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 - Allwell Health Inc (117644800)
Registrant - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650498244ANALYSIS(80539-001) , MANUFACTURE(80539-001)

Revised: 3/2021
Document Id: 12d48ef6-ccf1-4bc3-8469-0061bb083f7c
Set id: 12d48ef6-ccf1-4bc3-8469-0061bb083f7c
Version: 1
Effective Time: 20210301
 
Allwell Health Inc