Ocufresh Liquid
FDA Label NDC 64108-313

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Optics Laboratory Inc. for the product Ocufresh (NDC 64108-313). 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 factsactive ingredient (in each ml), 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

Drug Factsactive Ingredient (In Each Ml)

PURIFIED WATER 98.8%

Purpose

Eye Washing

Use:

  • for cleaning the eye to help relieve irritation, discomfort, burning, stinging, smarting or itching by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water.

Warnings:

To avoid contamination, do not touch tip of the container to any surface. Do not reuse. Onced open, 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 eye
  • if solution changes colors or becomes cloudy, do not use.

Keep Out Of Reach Of Children

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
  • control rate of flow by pressure on bottle
  • flush affected area as needed

    • Without Cup

    • hold container a few inches above the eye
    • control rate of flow by pressure on bottle
    • flush affected area as needed

      • With Cup

      • rinse cup with clean water immediately before each use. Avoid contamination of rim and inside surfaceof cup
      • fill cup half full with OcuFresh Eye Wash and apply the cup to the affected eye , pressing tightly to prevent escape of the liquid, and tilt the head backward
      • open eyelids wide and rotate eyeball to ensure thorough bathing with the wash
      • rinse cup with clean water after each use

Other Information:

Store at room temperature

15-30°C (59-86°F)

Inactive Ingredients:

Sodium Chloride, Sodium Borate, Boric Acid, benzalkonium Chloride

Questions Or Comments?

800-968-6788

Ocufresh Product Label

OPTICS®

Laboratory

OcuFresh®

Eye Wash

The Safe Choice for Cleansing Your Eyes

60 Sterile Single-Use Bottles

Each bottle contains: 20 ml (0.68 fl oz)

OcuFresh® cleanses your eyes to remove loose foreign material, pollen or chlorinated water to help relieve your eyes from:

Irritation • Stinging • Burning • Discomfort

Manufactured for: Optics Laboratory, Inc., El Monte, CA 91731 USA

Made ib Taiwan

Optics Laboratory and ocufresh are trademarksof: Optics Laboratory, inc

©2015 Optics Laboratory, Inc.

OPTICS®

Laboratory

OcuFresh®

Eye Wash

Sterile in Single-Use Bottles

The Safe Choice for Cleansing Your Eyes

6 Sterile Single-Use Bottles      Sterile Eye Cup Included

Convenient and easy to carry

Use only if tab and single-use bottles are intact

* Please review the disclaimer below.