Label: SOUNDBODY ARTIFICIAL TEARS- glycerin, hypromelloses, polyethylene glycol 400 liquid

  • 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 30, 2018

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  • Active Ingredient

    Glycerin 0.2%

    Hypromellose 0.2%

    Polyethylene Glycol 400 1%

  • Purpose

    Lubricant

    Lubricant

    Lubricant

  • Use

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for protection against further irritation
  • Warnings


    When using this product

    • remove contact lenses before using
    • do not use if this solution changes color or become cloudy
    • 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 feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • Put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • Other information

    • store between 15° to 25°C (59°F to 77°F)


  • Inactive ingredients

    Ascorbic acid, benzalkonium chloride, boric acid, dextrose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

  • Package principal display panel

    Soundbody Artificial Tears

    carton

  • INGREDIENTS AND APPEARANCE
    SOUNDBODY ARTIFICIAL TEARS 
    glycerin, hypromelloses, polyethylene glycol 400 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0650
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES2 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0650-51 in 1 BOX05/30/2018
    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 finalpart34905/30/2018
    Labeler - Kareway Product, Inc. (121840057)
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