Diaper Rash Cream 2.5oz

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Diaper Rash Cream 2.5oz is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Rejoice International Corp. 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 20231204.

Generic name
ZINC OXIDE
Manufacturer
Rejoice International Corp.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
57337-151
Application
M016
Label effective
20231204

About this product

Diaper Rash Cream 2.5oz is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Rejoice International Corp. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 57337-151, application M016, label effective 20231204. 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. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Zinc Oxide 40%

Indications & Usage

Use helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage & Administration

Directions change wet and soilded diapers promtly cleanse the diaper area allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged.

Warnings

Warnings For external use only Stop use and ask a doctor if Stop use and ask a doctor if condition worsen symptoms last more than 7 days or clear up and occur again within a few days When using this product When using this product do not get into eyes. 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 Diaper Rash Cream 2.5oz used for?
Use helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Who makes Diaper Rash Cream 2.5oz?
Rejoice International Corp. is the labeler of record for Diaper Rash Cream 2.5oz. 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 Diaper Rash Cream 2.5oz 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 Diaper Rash Cream 2.5oz 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 Diaper Rash Cream 2.5oz 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.