Diaper Rash Cream

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Diaper Rash Cream is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Foshan Desha Biotechnology Co., Ltd. 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 20260618.

Generic name
ZINC OXIDE
Manufacturer
Foshan Desha Biotechnology Co., Ltd.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
87781-001
Application
M016
Label effective
20260618

About this product

Diaper Rash Cream is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Foshan Desha Biotechnology Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87781-001, application M016, label effective 20260618. 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, minor irritation, product avoid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications & Usage

Uses Helps treat and prevent diaper rash Protects chafed skin and minor irritation associated with diaper rash Helps seal out wetness When using this product Avoid contact with eyes during use.

Dosage & Administration

Directions Change wet or soiled diapers promptly. Clean the diaper area and let it dry. Apply diaper cream as needed during each diaper change, especially before bedtime or when in contact with a wet diaper for a long time.

Warnings

Warnings For external use only.

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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

Recall and safety notices

1 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-0604-2017 A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981 Bayer HealthCare Pharmaceuticals, Inc. Class III Terminated 20170329

Frequently asked questions

What is Diaper Rash Cream used for?
Uses Helps treat and prevent diaper rash Protects chafed skin and minor irritation associated with diaper rash Helps seal out wetness When using this product Avoid contact with eyes during use.

Who makes Diaper Rash Cream?
Foshan Desha Biotechnology Co., Ltd. is the labeler of record for Diaper Rash Cream. 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 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 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 been recalled?
1 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.