Eyewash
FDA Label NDC 71271-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliance Medical Ltd for the product Eyewash (NDC 71271-100). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
