FDA Label for Eye Irrigating

View Indications, Usage & Precautions

Eye Irrigating Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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.

Active Ingredient



Purified water 99.05%


Purpose



Eyewash


Uses



washes the eye to help relieve:

  • •irritation
  • •stinging
  • •itching
    by removing:
  • •loose foreign material
  • •air pollutants (smog or pollen)
  • •chlorinated water

Warnings



Do not use if solution changes color or becomes cloudy

When using this product  

  • •remove contact lenses before use
  • •do not touch tip of container to any surface to avoid contamination
  • •replace cap after 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
    • •you have open wounds in or near the eye

Keep Out Of Reach Of Children.



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


Directions



  • •flush the affected eye(s) as needed
  • •control the rate of flow of solution by placing pressure on the bottle
  • When using an eye cup

    • •rinse the cup with clean water immediately before each use
    • •avoid contamination of the rim and inside surfaces of the cup
    • •fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
    • •tilt the head backward. Open eyelid wide and rotate eyeball to ensure thorough bathing with the wash
    • •rinse the cup with clean water after each use

Other Information



  • •store at 15° - 30°C (59° - 86°F)
  • •keep tightly closed

Inactive Ingredients



boric acid, sodium borate and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: edetate disodium 0.025% and sorbic acid 0.1%.


Questions Or Comments?



1-800-645-2158

Serious side effects associated with use of this product may be reported to this number.

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

© Rugby Laboratories
REV. 04/13 R-115

Re-order No. 370044

6998603

AK07025


How Supplied



Product: 50090-0382

NDC: 50090-0382-0 118 mL in a BOTTLE


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