GOODSENSE ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION [PROFICIENT RX LP]

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GOODSENSE ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION [PROFICIENT RX LP]
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NDC 63187-298-15
Set ID f29c792c-6cb2-449f-b97d-6304a58dec2a
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number PART349
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  • PURPOSE

    Uses

    •
    temporary relieves burning and irritations due to dryness of the eye(s)
    •
    protects against further irritation
  • WARNINGS

    Warnings

    For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

  • WHEN USING

    When using this product

    •
    remove contact lenses before using
    •
    do not touch tip of container to any surface to avoid contamination
    •
    replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    •
    you feel eye pain
    •
    changes in vision occur
    •
    redness or irritation of the eye gets worse or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    •
    Instill 1 or 2 drops in the affected eye(s) as needed.
    •
    Store at 15-25C (59-77F).
    •
    Children under 6 years of age: Ask a doctor

    Dosage and Administration

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

    Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

  • PRINCIPAL DISPLAY PANEL

    63187-298-15Relabeled By:

    Proficient Rx LP

    Thousand Oaks, CA 91320

  • INGREDIENTS AND APPEARANCE
    GOODSENSE ARTIFICIAL TEARS 
    polyvinyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-298(NDC:11716-0001)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-298-151 in 1 CARTON01/01/2019
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/22/2010
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-298) , RELABEL(63187-298)
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