Aerowash Eyewash And Skin-rinse
FDA Label NDC 55305-112

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aero Healthcare for the product Aerowash Eyewash And Skin-rinse (NDC 55305-112). 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.

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
sodium phosphate, monobasic

Other

  
Manufactured for:

Aero Healthcare

Congers, NY 10989

Made in Singapore

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