Label: IMPROVUE LUBRICANT (hypromellose 2208- 15000 mpa.s 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 1, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hypromellose (1.7%)

  • Purpose

    Ophthalmic Lubricant

  • Indications

    • For the temporary relief of burning and irritation due to dryness of the eye.
    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • Warnings

    • For external use only.
    • To avoid contamination do not touch tip of container or applicator to any surface.
    • Do not reuse. Once opened, discard.

    Stop use and ask a doctor if

    • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
    • If solution changes color or becomes cloudy, do not use.

    Keep out of reach of children

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

    • Remove cap from syringe and screw on applicator tip.
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Other Information

    • Do not use if pouch is damaged or has been previously opened.
    • Protect from freezing
    • Store at or below 25°C (77°F)
  • Inactive Ingredients

    Calcium chloride dihydrate, hydrochloric acid1, magnesium chloride hexahydrate, potassium chloride, purified water, sodium acetate trihydrate, sodium chloride, sodium citrate dihydrate, and sodium hydroxide1

    1
    May contain one or more of these ingredients for pH adjustment
  • Questions or Comments?

    (855) 734-2466 or (772) 236-2622 or log onto www.oculussurgical.com

  • PRINCIPAL DISPLAY PANEL - 6 Pouch Carton

    ImproVue®

    Ophthalmic Lubricant Drops

    • Sterile
    • Preservative-free
    • Single use, disposable container

    Contains:

    6 Pouches, each Pouch containing
    1 Single Use Syringe, 0.07 fl oz (2 ml)
    1 Single Use Applicator Tip

    OCULUS®
    SURGICAL
    www.oculussurgical.com

    Principal Display Panel - 6 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    IMPROVUE   LUBRICANT
    hypromellose 2208 (15000 mpa.s) solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62144-5510
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) (HYPROMELLOSE 2208 (15000 MPA.S) - UNII:Z78RG6M2N2) HYPROMELLOSE 2208 (15000 MPA.S)17 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Acetate (UNII: 4550K0SC9B)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Trisodium Citrate Dihydrate (UNII: B22547B95K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62144-5510-56 in 1 CARTON06/25/2014
    11 in 1 POUCH
    12 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34906/25/2014
    Labeler - Oculus Surgical, Inc. (015409582)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS Medical, Inc.194121018MANUFACTURE(62144-5510)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS Medical, Inc.024362989PACK(62144-5510)
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