Diaper Rash

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Diaper Rash is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Aldermed Inc. 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 20260509.

Generic name
ZINC OXIDE
Manufacturer
Aldermed Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
87236-018
Application
M016
Label effective
20260509

About this product

Diaper Rash is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Aldermed Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87236-018, application M016, label effective 20260509. 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

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

Dosage & Administration

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

Warnings

Warnings For External Use Only When using this product do not get into eyes Stop use and ask a doctor if Conditions worsens Symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

More products with the same ingredient

ZINC OXIDE

100% Pure Yerba Mate MIst SPF 30

Purity Cosmetics View label

365 WHOLE FOODS MARKET MINERAL SPF 30

Whole Foods Market, Inc. View label

365 WHOLE FOODS MARKET MINERAL SPF 50

Whole Foods Market, Inc. View label

365 WHOLE FOODS MARKET SPORT MINERAL SPF 30

Whole Foods Market, Inc. View label

4ocean REEF SAFE SUNSCREEN SPF 40

Stream2Sea, LLC View label

6000X Elemental Screen BS SPF 30 Sunscreen

Allure Labs View label

ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX

SIBORG LLC View label

ALL WEATHER SPF 15 LIP BALM

Burt's Bees View label

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

3 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-1322-2022 A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3. Mckesson Medical-Surgical Inc. Corporate Office Class II Terminated 20220817
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
D-1652-2012 Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01. Victus, Inc. Class II Terminated 20120829

Frequently asked questions

What is Diaper Rash used for?
Uses ■ helps treat and prevent diaper rash ■ protects chafed skin due to diaper rash and helps seal out wetness

Who makes Diaper Rash?
Aldermed Inc. is the labeler of record for Diaper Rash. 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 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 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 been recalled?
3 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.