Buffered Eye-lert
FDA Label NDC 0498-0160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by North Safety Products for the product Buffered Eye-lert (NDC 0498-0160). 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, uses, warnings, do not use, when using this product, ask doctor if you have, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Purified water 98%

Purpose

Emergency eyewash and skin flush

Uses

for flushing the eye and skin to reduce chances of severe injury caused by acid, alkali or particulate contamination.

Warnings

For external use only

Do Not Use

  • for injection
  • in intraocular surgery
  • internally
  • if solution changes color or becomes cloudy

When Using This Product

  • avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard
  • obtain immediate medical treatment for all open wounds in or near the eyes

Ask Doctor If You Have

  • eye pain
  • changes in vision
  • redness or irritation of the eye after use
  • an injury caused by an alkai
  • condition worsens or persists

Otc - Keep Out Of Reach Of Children

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

Directions

  • do not dilute solution or reuse bottle
  • hold container a few inches above the eye or skin
  • control flow of solution by pressure on bottle
  • flush affected area as needed a minimum of 20 minutes


Other Information

  • tamper evident: do not use if twist off top is broken or missing
  • not for use as a contact lens solution
  • twist cap to open
  • use before expiration date marked on bottle
  • store at room temperature, 15o to 30oC  (59o to 86o)

Inactive Ingredients

benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate

Questions

Questions or comments?  Call toll free number 1-800-130-4110

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