Label: SOUND BODY ARTIFICIAL TEARS- polyvinyl alcohol, povidone 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 February 25, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients                                              Purpose

    Polyvinyl alcohol 0.5%..................................... Lubricant

    Povidone 0.6%............................................... Lubricant

  • PURPOSE

    Uses

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

    Warnings

    For external use only

  • DO NOT USE

    Do not use: if this solution changes color or becoems cloudy or if you are sensitive to any ingredient in this product

  • WHEN USING

    When using this product

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

    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
    • children under 6 years of age; ask a doctor
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store at 15° to 25°C (59° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, potassium chloride, purified water, sodium borate, and sodium chloride

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SOUND BODY ARTIFICIAL TEARS 
    polyvinyl alcohol, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-565
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL5 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-565-151 in 1 BOX
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/25/2014
    Labeler - United Exchange Corp. (840130579)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!