Fad First Aid Direct Eyewash
FDA Label NDC 42961-090

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product Fad First Aid Direct Eyewash (NDC 42961-090). 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, directions, other information, inactive ingredients, package/label principal display panel – eyewash flushing solution, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Purified water 98.577% w/v

Purpose

eye wash

Uses

  • For flushing the eye to remove loose foreign material or air pollutants (smog or pollen)

Warnings

For external use only

Do not use

  • If solution changes color or becomes cloudy

    • When using this product

    • Remove contact lenses before using
    • Avoid contamination, do not touch tip of container to any surface
    • Do not reuse, once open, discard

      • Stop use and ask a doctor if

      • You experience eye pain
      • Changes in vision occur
      • Continued redness or irritation of the eye or if the condition worsens or persists
      • Obtain immediate medical treatment for all open wounds in or near the eyes

Directions

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

Other Information

  • Store out of direct sunlight 2°-40°C (36°-104°F)
  • Use at 15°-30°C (59°-86°F)
  • Do not use if twist-off top is broken or missing

Inactive Ingredients

disodium EDTA, polyhexanide (PHMB), sodium chloride, sodium hydroxide, sodium phosphate dibasic, sodium phosphate monobasic

Package/Label Principal Display Panel – Eyewash Flushing Solution

Eyewash Flushing Solution Label (Image 03)

Eyewash Flushing Solution Label (Image 03)

Eyewash

FLUSHING SOLUTION

Sterile
Isotonic Buffered
Flushing Solution

Single Use Only

CAUTION: Tamper-evident cap.
Do not use if twist-off top is broken or missing.

4 fl. oz. (118 mL)

Package/Label Principal Display Panel – Xpect First Aid Buffered Eye & Skin

Xpect First Aid Buffered Eye & Skin Label (Image 04)

Xpect First Aid Buffered Eye & Skin Label (Image 04)

BUFFERED
Eye & Skin

Sterile Isotonic
Buffered Flushing Solution

Single use only

CAUTION: Tamper-evident cap.
Do not use if twist-off top is broken or missing.

4 fl. oz. (118 mL)

Xpect®
First aid

Package/Label Principal Display Panel – Fad First Aid Direct Buffered Eye & Skin

Fad First Aid Direct Buffered Eye & Skin Sterile Isotonic Buffered Flushing Solution Label (Image 05)

Fad First Aid Direct Buffered Eye & Skin Sterile Isotonic Buffered Flushing Solution Label (Image 05)

BUFFERED
Eye & Skin

Sterile
Isotonic Buffered
Flushing Solution

SINGLE USE ONLY

CAUTION: Tamper-evident cap. Do not use if twist-off top is broken or missing.

8 fl. oz. (236 mL)

fad first aid direct®

Fad First Aid Direct Buffered Eye & Skin Sterile Isotonic Buffered Flushing Solution Label (Image 06)

Fad First Aid Direct Buffered Eye & Skin Sterile Isotonic Buffered Flushing Solution Label (Image 06)

BUFFERED
Eye & Skin

Sterile
Isotonic Buffered
Flushing Solution

SINGLE USE ONLY

CAUTION: Tamper-evident cap. Do not use if twist-off top is broken or missing.

16 fl. oz. (474 mL)

fad first aid direct®

* Please review the disclaimer below.