Label: C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS- fluorescein sodium strip

  • NDC Code(s): 83851-100-05, 83851-100-10, 83851-100-30
  • Packager: Vistamerica USA
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated October 1, 2024

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  • Product Facts

    Each sterile strip is impregnated with 1 mg. of fluorescein sodium U.S.P.

  • INDICATIONS:

    Intended for use when fitting contact lenses.

  • DIRECTIONS FOR USE:

    To insure full fluorescence and patient comfort, the impregnated tip should be moistened before application. One or two drops of sterile irrigating or saline solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

    83851-100: Vista Fluroescein Sodium

    Grasp tabs between thumbs & index fingers

    Gently pull tabs apart

    Remove strip taking care to touch only the white portion of the strip

  • STORAGE:

    Store at 10 oC - 30 oC.

  • NOTE:

    For external use only. Contents may not be sterile if individual strips have been damaged or previously opened.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • HOW SUPPLIED:

    Dispenser carton containing 50, 100, or 300 strips.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Madhu Instruments Pvt. Ltd.

    A-260, Okhla Industrial Area, Phase-1, New Delhi-110 020 India

    DUNS number - 91-582-7852

    M.L.: S(0116)/MB/18

    Vistamerica USA

    20 Perkins Dr, Prescott

    AZ 86301

  • Representative Packaging:

    83851-100: Fluorescein Sodium Ophthalmic Strip How Used (above)

    83851-100: Fluorescein Sodium How Used (above) 83851-100: Fluorescein Sodium Ophthalmic Strip Box (above)83851-100: Fluorescein Sodium Ophthalmic Strip Box (above)

    Vista Fluorescein Sodium Ophthalmic Strip (Individual Pouch) 83851-100

    83851-100: Fluorescein Sodium Ophthalmic Strip Individual Pouch (above)

  • INGREDIENTS AND APPEARANCE
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS 
    fluorescein sodium strip
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:83851-100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN SODIUM1 mg  in 1 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83851-100-10100 in 1 BOX10/01/2024
    11 mg in 1 PACKET; Type 0: Not a Combination Product
    2NDC:83851-100-30300 in 1 BOX10/01/2024
    21 mg in 1 PACKET; Type 0: Not a Combination Product
    3NDC:83851-100-0550 in 1 BOX10/01/2024
    31 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2024
    Labeler - Vistamerica USA (122342378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Madhu Instruments Pvt.Ltd.915827852manufacture(83851-100)
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