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  5. Label Information: Rugby Eye Wash

FDA Label for Rugby Eye Wash

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER SAFETY INFORMATION
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby Eye Wash Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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%)


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