Label: MAJOR LIQUITEARS- polyvinyl alcohol solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 1, 2019

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  • 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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