Label: LUMIFY PRESERVATIVE FREE EYE DROPS- brimonidine tartrate solution/ drops

  • NDC Code(s): 24208-538-05, 24208-538-20
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 28, 2025

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  • Active ingredient

    Brimonidine tartrate (0.025%)

  • Purpose

    Redness reliever

  • Use

    • relieves redness of the eye due to minor eye irritations
  • Warnings

    For external use only

  • Do not use

    • if solution changes color or becomes cloudy
    • if single-use vial is not intact
  • Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 3 days
  • If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

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

  • Directions

    • adults and children 5 years of age and over:
      • twist tab completely off to open vial
      • instill 1 drop in the affected eye(s)
      • discard vial immediately after use; do not re-use
      • store unused single-use vials in the child-resistant carton
      • do not use more than 4 times daily
      • remove contact lenses before use
      • wait at least 10 minutes before re-inserting contact lenses after use
      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
      • to avoid contamination, do not touch tip of container to any surface
    • children under 5 years of age: consult a doctor
  • Other information

    • store at 15-25 °C (59-77 °F)
    • use only if pouch is sealed and single-use vial is intact
    • this carton is child-resistant
  • Inactive Ingredients

    boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

  • Questions or comments?[phone icon] call: 1-800-553-5340

  • Package/Label Principal Display Panel- 20 ct Carton

    BAUSCH + LOMB

    NDC 24208-538-20

    NEW

    [Eye Image]

    LUMIFY ®

    PRESERVATIVE FREE

    BRIMONIDINE TARTRATE
    OPHTHALMIC SOLUTION 0.025%
    REDNESS RELIEVER EYE DROPS

    • Now available in preservative free
    • Works in 1 minute
    • Convenient single-use vials

    20 single-use vials (4 pouches x 5 single-use vials)

    0.013 FL OZ (0.4 mL) per vial

    [vial icon]
    Sterile

    622309
    3907900

    carton
  • INGREDIENTS AND APPEARANCE
    LUMIFY PRESERVATIVE FREE EYE DROPS 
    brimonidine tartrate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-538
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE) BRIMONIDINE TARTRATE0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-538-055 in 1 POUCH01/01/2025
    10.4 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:24208-538-204 in 1 CARTON01/01/2025
    25 in 1 POUCH
    20.4 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21842401/01/2025
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625pack(24208-538)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Unither574139809manufacture(24208-538)
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