Real Eyewash
FDA Label NDC 59276-208

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oliver Landon Intl Inc. for the product Real Eyewash (NDC 59276-208). 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 active ingredient, purpose, use, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Purified water USP

98.577% w/v

Purpose

Eyewash

Use

Use for flushing the eye to remove loose foreign material.

Warnings

For external use only

  • To avoid contamination, do not touch tip of container to any surface
  • Do not reuse
  • Once opened, discard
  • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor
  • Obtain immediate medical treatment for all open wounds in or near the eyes
  • If solution changes color or becomes cloudy, do not use; nor, if twist-off Tamper Evident top is broken or missing

Keep Out Of Reach Of Children

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

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other Information

  • Store at 36° - 104°F
  • Use at 59° - 86°F
  • Keep out of direct sunlight

Inactive Ingredients

Disodium EDTA

Polyhexanide

Sodium Chloride

Sodium Hydroxide

Sodium Phosphate, Dibasic dodecahydrate

Sodium Phosphate, Monobasic dihydrate


Other

Manufactured in Singapore

Oliver Landon Intl Inc.

The Grove 21 Pine Road
Belleville, St. Michael,
BB 11113
Barbados © 2018

All Rights Reserved.


[email protected]

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