Retaine Ultra PF

POLYETHYLENE GLYCOL OPHTHALMIC HUMAN OTC DRUG

Retaine Ultra PF is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL manufactured by OCuSOFT LLC 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 20260413.

Generic name
POLYETHYLENE GLYCOL
Manufacturer
OCuSOFT LLC
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Dosage form
N/A
NDC
54799-470
Application
M018
Label effective
20260413

About this product

Retaine Ultra PF is an FDA-registered drug product whose active ingredient is POLYETHYLENE GLYCOL. It is labelled by OCuSOFT LLC taken by ophthalmic and marketed as a human otc drug product. Identifiers on file: NDC 54799-470, application M018, label effective 20260413. It is one of 2 FDA drug label records sharing the active ingredient POLYETHYLENE GLYCOL. 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 POLYETHYLENE GLYCOL are most often described in connection with: relieves dryness, temporary relief, burning irritation, discomfort due, eye exposure, protectant against. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Purpose Polyethylene Glycol 400 (0.4%).................. Lubricant Propylene Glycol 0.3%............................... Lubricant

Indications & Usage

Uses relieves dryness of the eye. for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to the wind and sun. may be used as a protectant against further irritation.

Dosage & Administration

Directions instill 1 or 2 drops in the affected eye(s) as needed

Warnings

Warnings For use in the eyes only. Retain outer carton for full product drug facts.

More products with the same ingredient

POLYETHYLENE GLYCOL

Polyethylene Glycol

BluePoint Laboratories View label

How products containing POLYETHYLENE GLYCOL compare

FDA lists 2 drug label records with POLYETHYLENE GLYCOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — BluePoint Laboratories 1
— — OCuSOFT LLC 1
— — — —
— — — —
— — — —

Frequently asked questions

What is Retaine Ultra PF used for?
Uses relieves dryness of the eye. for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to the wind and sun. may be used as a protectant against further irritation.

Who makes Retaine Ultra PF?
OCuSOFT LLC is the labeler of record for Retaine Ultra PF. 2 FDA label records share the active ingredient POLYETHYLENE GLYCOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Retaine Ultra PF 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 Retaine Ultra PF 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.

Are there other products containing POLYETHYLENE GLYCOL?
Yes. 2 FDA drug label records list POLYETHYLENE GLYCOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Retaine Ultra PF been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.