Sheffield Zinc Oxide

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Sheffield Zinc Oxide is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Sheffield Pharmaceuticals LLC administered by TOPICAL. 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 20231128.

Generic name
ZINC OXIDE
Manufacturer
Sheffield Pharmaceuticals LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
11527-065
Application
M016
Label effective
20231128

About this product

Sheffield Zinc Oxide is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Sheffield Pharmaceuticals LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 11527-065, application M016, label effective 20231128. It is one of 404 FDA drug label records sharing the active ingredient ZINC OXIDE. 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 ZINC OXIDE are most often described in connection with: diaper rash, helps treat, protects chafed, skin due, wetness dries, weeping poison. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Zinc oxide 20%

Indications & Usage

Uses helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Dosage & Administration

Directions apply liberally as often as necessary For diaper rash: change wet or soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Warnings

Warnings For external use only When using this product, avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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How products containing ZINC OXIDE compare

FDA lists 404 drug label records with ZINC OXIDE 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
— — Ilia, Inc. 30
— — COSMAX USA, CORP 24
— — Colorescience 16
— — Allure Labs Inc 9
— — Raw Elements LLC 9

Frequently asked questions

What is Sheffield Zinc Oxide used for?
Uses helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Who makes Sheffield Zinc Oxide?
Sheffield Pharmaceuticals LLC is the labeler of record for Sheffield Zinc Oxide. 404 FDA label records share the active ingredient ZINC OXIDE, 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 Sheffield Zinc Oxide come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sheffield Zinc Oxide 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 ZINC OXIDE?
Yes. 404 FDA drug label records list ZINC OXIDE 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 Sheffield Zinc Oxide 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.