Label: ARTIFICIAL TEARS- 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 May 15, 2023

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  • Drug Facts

  • Active Ingredient

    Polyvinyl Alcohol 1.4%

  • Purpose

    Eye Lubricant

  • Uses

    • relieves dryness of the eye
    • prevents further irritation
  • Warnings

    Do not use

    • if solution changes colour or becomes cloudy 
    • with contact lenses

    When using this product

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

    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

    • if swallowed, get medical help or contact a poison control center right away.
  • QUESTIONS

    Question or comments?

    1-844-500-2729

    between 9 am and 4 pm EST, Monday-Friday.

  • Directions

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

  • Other information

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

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

  • SPL UNCLASSIFIED SECTION

    Compare to the active Ingredient in Liquifilm Tears Eye Drops

    Lubricant Eye Drops

    Prevents Irritation and Relieves Dryness of the eye

    Distributed by.

    ARU PARMA INC.

    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Qpack1

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-920
    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, DODECAHYDRATE (UNII: E1W4N241FO)  
    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:70403-920-151 in 1 CARTON03/31/202003/31/2025
    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 finalpart34903/31/202003/31/2025
    Labeler - Aru Pharma Inc. (079736192)
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