FDA Label for Eyewash

View Indications, Usage & Precautions

Eyewash Product Label

The following document was submitted to the FDA by the labeler of this product Reliance Medical Ltd. 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.

Drug Facts




Active Ingredient



Purified Water 99.1 %


Purpose



Eyewash


Uses



For cleansing the eye to remove loose foreign material.


Warnings



For external use only.

Do not use

• if solution changes colour or becomes cloudy

• for injection

• as a contact lens solution.

When using the product

• do not re-use, once opened, discard.

• to avoid contamination, do not touch the tip of the container to any surface.

Stop use and consult a doctor if

• you experience eye pain.

• changes in vision.

• continued redness or irritation of the eye.

• the condition worsens or persists.

Obtain immediate medical treatment for all open wounds in or near the eyes.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

• If swallowed, get medical help or contact Poison Control Centre right away.


Directions



• smoothly twist the lid in either direction to break the seal and remove the lid. • position the bottle above the eye and gently squeeze.
• flush the affected eye as needed controlling the rate of flow of solution by pressure on the bottle. • cleanse the eye(s) with as much solution as required.


Other Information



• store between 5°C and 35°C (41° to 95° F).

• use before expiry date.

• do not use if seal is broken prior to use.


Inactive Ingredient



Sodium chloride.


Questions?



Call 1-844-405-7233. Monday - Friday, 9am - 5pm. You may also report serious side effects to this number.


Other



MANUFACTURED FOR:

Reliance Medical LTD, Radnor Park Trading

Estate, Congleton, Cheshire, England, CW12 4XP, UK.

IMPORTED AND DISTRIBUTED BY:

Innovative Safety Supply USA Inc. 5150 West 76th St. Indianapolis,

IN, 46268 USA.

MADE IN CHINA

Compliance:

ANSI/ISEA Z358.1-2014

(As Personal Eye Wash Only)


* Please review the disclaimer below.