Rugby Eye Wash Solution
FDA Label NDC 0536-1224

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Eye Wash (NDC 0536-1224). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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 (99.05%)

Otc - Purpose

Purpose

Eyewash

Indications & Usage

Uses

washes the eye to help relieve

  • irritation
  • discomfort
  • burning
  • stinging
  • itching

    • by removing

    • loose foreign material
    • air pollutants (smog or pollen)
    • chlorinated water

Warnings

Warnings
For external use only

Otc - Do Not Use

Do not use

  • if you have open wounds in or near the eyes, and get medical help right away
  • if solution changes color or becomes cloudy

Otc - When Using

When using this product

  • remove contact lenses before using
  • do not touch the tip of container to any surface to avoid contamination
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if
• you experience eye pain, changes in vision, continued redness or irritation of the eye
• condition worsens or persists

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

For use with nozzle applicator

  • flush the affected eye(s) as needed
  • control the rate of flow of solution by pressure on the bottle
  • do not touch dropper tip to eye

    • When using an eye cup

    • rinse the cup with Eye Wash Solution immediately before each use
    • avoid contamination of the rim and inside surfaces of the cup
    • fill the cup half full with Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage
    • tilt the head backward.  Open eyelids wide and rotate eyeball to thoroughly wash the eye
    • rinse cup with clean water after each use
    • replace cap after use

Other Safety Information

Other information

  • Store at 15°-25°C (59°-77°F)
  • keep tightly closed
  • does not contain thimerosal
  • enclosed eyecup is sterile if packaging is intact
  • use before expiration date marked on the carton or bottle

Inactive Ingredient

Inactive ingredients

boric acid, sodium borate and sodium chloride.  PRESERVATIVE ADDED: BENZALKONIUM CHLORIDE (0.01%)

* Please review the disclaimer below.