Improvue Solution/ Drops
FDA Label NDC 62144-5510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oculus Surgical, Inc. for the product Improvue (NDC 62144-5510). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, indications, warnings, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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 acid

May contain one or more of these ingredients for pH adjustment

, magnesium chloride hexahydrate, potassium chloride, purified water, sodium acetate trihydrate, sodium chloride, sodium citrate dihydrate, and sodium hydroxide

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)

    Principal Display Panel (6 Pouch Carton)

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