MAJOR LIQUITEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [PROFICIENT RX LP]

MAJOR LIQUITEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [PROFICIENT RX LP]
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NDC 71205-139-15
Set ID 273802ce-cc8d-4186-a8f2-b0208b1653be
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredient                                                Purpose

    Polyvinyl Alcohol 1.4%..................................... Lubricant

  • PURPOSE

    Uses

    to prevent further irritation
    to relieve dryness of the eye
  • WARNINGS

    Warnings

    Do not use

    if solution changes color or becomes cloudy
  • WHEN USING

    When using this product

    do not touch tip of container to any surface to avoid contamination
    replace cap after each use
  • ASK DOCTOR

    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 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    instill 1 to 2 drops in the affected eye(s) as needed
  • STORAGE AND HANDLING

    Other information

    store at 15°-25°C (59°-77°F)
    keep tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150 USA

    Relabeled By:

    Proficient Rx LP

    Thousand Oaks, CA 91320


    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    71205-139-15
  • INGREDIENTS AND APPEARANCE
    MAJOR LIQUITEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-139(NDC:0904-6492)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-139-151 in 1 CARTON10/01/2018
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/17/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-139)

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