Label: LASTACAFT- alcaftadine solution/ drops

  • NDC Code(s): 0023-4291-01, 0023-4291-05, 0023-4291-06, 0023-4291-07, view more
    0023-4291-10
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 10, 2022

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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°-25°C (59°-77°F)

  • Inactive ingredients

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

  • Questions or comments?

    telephone icon1.800.678.1605

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-4291-10
    ORIGINAL
    PRESCRIPTION STRENGTH
    LASTACAFT    ®
    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
    STERILE
    120 DAY SUPPLY
    Two 5 mL bottles (0.17 fl oz each)

    NDC 0023-4291-10 ORIGINAL PRESCRIPTION STRENGTH LASTACAFT® 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 STERILE 120 DAY SUPPLY Two 5 mL bottles (0.17 fl oz each)

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-4291-05
    ORIGINAL
    PRESCRIPTION STRENGTH
    LASTACAFT    ®
    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
    STERILE
    60 DAY SUPPLY
    0.17 fl oz (5 mL)

    NDC 0023-4291-05 ORIGINAL PRESCRIPTION STRENGTH LASTACAFT® 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 STERILE 60 DAY SUPPLY 0.17 fl oz (5 mL)

  • INGREDIENTS AND APPEARANCE
    LASTACAFT 
    alcaftadine solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-4291
    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)  
    sodium phosphate, monobasic (UNII: 3980JIH2SW)  
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium hydroxide (UNII: 55X04QC32I)  
    hydrochloric acid (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-4291-051 in 1 CARTON12/01/2021
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0023-4291-102 in 1 CARTON12/01/2021
    25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0023-4291-011 in 1 CARTON12/01/2021
    31 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0023-4291-061 in 1 CARTON12/01/2021
    45 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:0023-4291-072 in 1 CARTON12/01/2021
    55 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02213412/01/2021
    Labeler - Allergan, Inc. (144796497)
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