Eyewash

EYEWASH OPHTHALMIC HUMAN OTC DRUG

Eyewash is an FDA drug label for the active ingredient EYEWASH manufactured by Global Equipment Company administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210617.

Generic name
EYEWASH
Manufacturer
Global Equipment Company
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Dosage form
N/A
NDC
78641-786
Application
NDA022305
Label effective
20210617

About this product

Eyewash is an FDA-registered drug product whose active ingredient is EYEWASH. It is labelled by Global Equipment Company taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 78641-786, application NDA022305, label effective 20210617. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing EYEWASH are most often described in connection with: eye help, relieve irritation, burning removing, loose foreign. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Purified water 98.3%

Indications & Usage

Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Dosage & Administration

Dosage and Administration remove tamper evident seal and cap avoid contamination of rim and inside surfaces of the nozzle place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Warnings

Warnings For external use only

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0461-2024 Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37 HONEYWELL INC Class II Terminated 20240501
D-0147-2019 Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12 Pharm D Solutions, LLC Class II Terminated 20181107
D-0146-2019 Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10 Pharm D Solutions, LLC Class II Terminated 20181107
D-1048-2018 Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY Longbow First Aid Products Manufactory Class II Terminated 20180815
D-1049-2018 Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211. Longbow First Aid Products Manufactory Class II Terminated 20180815

Frequently asked questions

What is Eyewash used for?
Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Who makes Eyewash?
Global Equipment Company is the labeler of record for Eyewash.

What form does Eyewash come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Eyewash prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Eyewash been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.