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• 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
Stop use and ask a doctor if
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• 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
When using an eye cup
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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