Label: VIVA- polysorbate 80 solution/ drops

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 25, 2012

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  • 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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