VIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]

VIVA (POLYSORBATE 80) SOLUTION/ DROPS [DAKOTA LABORATORIES, LLC]
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NDC 54891-001-02, 54891-001-03, 54891-001-04
Set ID 45ac4335-3ecd-4a03-865e-82dd9cd3c715
Category HUMAN OTC DRUG LABEL
Packager Dakota Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredients

    Polysorbate 80 (1.0%)

  • Purpose

    Eye Lubricant

  • Keep out of reach of children

    • Keep this and all drugs out of the reach of children.

  • INDICATIONS & USAGE

    • Temporarily relieves burning and irritation due to dryness of the eye.
    • Temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.
    • Protects against further irritation or relieves dryness of the eye.
    • Lubricates to prevent further irritation or to relieve dryness of the eye.

  • WARNINGS

    • To avoid contamination, do not touch tip of container to any surface.

    • Replace cap after using

    • If you experience pain, changes in vision, continued redness or irritation of the eye, or if the condition persists for more than 72 hours, discontinue use and consult a doctor.

    • If solution changes color or becomes cloudy, do not use.

  • DOSAGE & ADMINISTRATION

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • INACTIVE INGREDIENT

    purified water, sodium chloride, citric acid, edetate disodium with retinyl palmitate, mannitol, sodium citrate, and pyruvate as antioxidants.

  • PRINCIPAL DISPLAY PANEL

    Viva Drops 10mL Bottle Packaging
    Viva Drops 20 Pack of Unidose
    Viva Drops 2 Pack of Unidose
  • INGREDIENTS AND APPEARANCE
    VIVA 
    polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54891-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polysorbate 80 (UNII: 6OZP39ZG8H) (Sorbitan - UNII:6O92ICV9RU) Polysorbate 80100 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 60.5 mg  in 10 mL
    Citric Acid (UNII: 2968PHW8QP) .34 mg  in 10 mL
    Edetate Disodium (UNII: 7FLD91C86K) 5 mg  in 10 mL
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 5.5 mg  in 10 mL
    Mannitol (UNII: 3OWL53L36A) 18 mg  in 10 mL
    Sodium Citrate (UNII: 1Q73Q2JULR) 73.6 mg  in 10 mL
    Sodium Pyruvate (UNII: POD38AIF08) 5 mg  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54891-001-0210 mL in 1 BOTTLE
    2NDC:54891-001-04.5 mL in 1 VIAL, SINGLE-USE
    3NDC:54891-001-03.5 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/19/1987
    Labeler - Dakota Laboratories, LLC (002303871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dakota Laboratories, LLC002303871manufacture

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