Physicianscare Ophthalmic Solution Eyewash Solution
FDA Label NDC 0924-0160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Physicianscare Ophthalmic Solution Eyewash (NDC 0924-0160). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, information for patients, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Purified Water 98.3%

Otc - Purpose

Purpose

Eyewash

Indications & Usage


Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

Warnings

For external use only

 

Do not use

  • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
  • if solution changes color or becomes cloudy 

    • When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • do not reuse
    • once opened, discard 

      • Stop use and ask a doctor if you experience

      • changes in vision
      • eye pain
      • condition worsens or persists
      • continued redness or irritation of the eye

Otc - Keep Out Of Reach Of Children

 

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

 

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Information For Patients

 

Other information

  • lot number is printed on the bottle
  • store at 20° to 25° C [68° to 77° F]
  • for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"
  • do not use if this seal is missing or broken
  • use before expiration date marked on bottle

Inactive Ingredient

 

Inactive ingredients

boric acid, sodium borate, sodium chloride

Otc - Questions

Questions?  Call   1-800-835-2263

Package Label.Principal Display Panel

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