Label: ALCAFTADINE solution/ drops

  • NDC Code(s): 58602-605-40, 58602-605-42
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 23, 2023

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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

    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
    • to treat contact lens related irritation
  • When using this product

    • do not touch tip of container to any surface to avoid contamination
    • remove contact lenses before use
    • wait at least 10 minutes before reinserting contact lenses after use
    • do not wear a contact lens if your eye is red
  • Stop use and ask a doctor if

    you experience any of the following:

    • eye pain
    • changes in vision
    • increased redness of the eye
    • itching worsens or lasts for more than 72 hours
  • Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older:
      • put 1 drop in the affected eye(s) once daily,
      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
      • replace cap after each use
    • children under 2 years of age:
      • consult a doctor
  • Other information

    • only for use in the eye
    • store between 15° to 25°C (59° to 77°F)
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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