ALCAFTADINE - alcaftadine solution/ drops 
Aurohealth LLC

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Drug Facts

Active ingredient
Alcaftadine 0.25%

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 any of the following:

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, water for injection, sodium chloride, sodium hydroxide and/or hydrochloric acid

Questions?

✆1-855-274-4122
(Monday – Friday 8:30 AM to 5:00 PM EST).


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

Made in India
 
Revised: May 2023

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container Label)

AUROHEALTH                NDC 58602-605-40
Alcaftadine
Ophthalmic Solution
0.25%


Antihistamine Eye Drops
STERILE                                0.17 fl oz (5 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton)

AUROHEALTH                    NDC 58602-605-40
*Compare to the Active Ingredient in
Lastacaft® Once Daily Relief

Original Prescription Strength
Alcaftadine
Ophthalmic Solution
0.25%


Antihistamine Eye Drops
ONCE DAILY RELIEF
Eye Allergy Itch Relief

Works in Minutes
Relief from Allergens:
✓ Pet Dander ✓ Pollen
✓ Grass ✓ Ragweed

60 DAY SUPPLY
Sterile                             0.17 fl oz (5 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (10 mL Container Carton)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton) Twin Pack

AUROHEALTH                NDC 58602-605-42
*Compare to the Active Ingredient in
Lastacaft® Once Daily Relief
TWIN PACK
Original Prescription Strength
Alcaftadine
Ophthalmic Solution
0.25%

Antihistamine Eye Drops
ONCE DAILY RELIEF

Eye Allergy Itch Relief

Works in Minutes
Relief from Allergens:
✓ Pet Dander ✓ Pollen
✓ Grass ✓ Ragweed
120 DAY SUPPLY
Sterile                     Two 5 mL bottles (0.17 fl oz each)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container Carton) Twin Pack

ALCAFTADINE 
alcaftadine solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-605
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCAFTADINE (UNII: 7Z8O94ECSX) (ALCAFTADINE - UNII:7Z8O94ECSX) ALCAFTADINE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-605-401 in 1 CARTON06/23/2023
15 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:58602-605-422 in 1 CARTON06/23/2023
25 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21065906/23/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Eugia Pharma Specialities Limited650498244ANALYSIS(58602-605) , MANUFACTURE(58602-605) , PACK(58602-605)

Revised: 6/2023
Document Id: d550d462-ab7c-4703-9e6d-3b2360abac7d
Set id: d550d462-ab7c-4703-9e6d-3b2360abac7d
Version: 1
Effective Time: 20230623
 
Aurohealth LLC