Label: ALCAFTADINE solution/ drops

  • NDC Code(s): 68083-649-01, 68083-649-02
  • Packager: Gland Pharma Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 5, 2024

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  • 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 that 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 at 15° to 25°C (59° to 77°F)
  • Inactive ingredients


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

  • Questions or comments?

    866-770-7144

    (Monday – Friday 9:00 AM to 6:00 PM EST)


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

    Container Label - 0.25% (3 mL)

    NDC-68083-649-01
    Alcaftadine
    Ophthalmic Solution
    0.25%
    Antihistamine Eye Drops
    0.10 fl oz (3 mL)      Sterile

       alcaftadine-spl-container-label


      

    Container Carton - 0.25% (3 mL)


    ORIGINAL PRESCRIPTION STRENGTH
    NDC-68083-649-01           3 mL
    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

    40 DAY SUPPLY

    Sterile     0.10 fl oz (3 mL)


     

       

    alcaftadine-spl-carton-label-mono-pack

     

    Container Carton - 0.25% (3 mL) - Twin Pack


    ORIGINAL PRESCRIPTION STRENGTH

    TWIN PACK
    NDC-68083-649-02           3 mL
    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

    80 DAY SUPPLY

    Sterile     Two 3 mL bottles (0.10 fl oz each)

    alcaftadine-spl-carton-label-twin-pack

  • INGREDIENTS AND APPEARANCE
    ALCAFTADINE 
    alcaftadine solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68083-649
    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:68083-649-011 in 1 CARTON03/01/2024
    13 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:68083-649-022 in 1 CARTON03/01/2024
    23 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20970603/01/2024
    Labeler - Gland Pharma Limited (918601238)
    Establishment
    NameAddressID/FEIBusiness Operations
    GLAND PHARMA LIMITED918601238ANALYSIS(68083-649) , LABEL(68083-649) , MANUFACTURE(68083-649) , PACK(68083-649)
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