Label: AVENOVA LUBRICANT EYE DROPS HIGH PERFORMANCE- polyethylene glycol 400, propylene glycol 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 September 28, 2021

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

  • Active ingredients

    Polyethylene glycol 400 0.4%

    Propylene glycol 0.3%

  • Purposes

    Lubricant

    Lubricant

  • Use

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

    For external use only

    Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    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 feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse 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 (1-800-222-1222) right away.

  • Directions

    instill 1 to 2 drops in the affected eye(s) as needed

  • Other information

    store at 15°-30°C (59°-86°F)

  • Inactive ingredients

    aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

  • Questions or comments?

    Call 1-800-890-0329

    Email: sales@avenova.com

  • Avenova Lubricant Eye Drops High Performance 15mL twin pk

    Avenova Lubricant Eye Drops High Performance 15mL twin pk

  • INGREDIENTS AND APPEARANCE
    AVENOVA LUBRICANT EYE DROPS HIGH PERFORMANCE 
    polyethylene glycol 400, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81963-101
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81963-101-102 in 1 BOX09/28/2021
    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 finalpart34909/28/2021
    Labeler - NovaBay Pharmaceuticals, Inc. (191505192)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(81963-101) , pack(81963-101) , label(81963-101)