FDA.reportPublic FDA data

Dr. Smith's Diaper Rash Ointment

Manufacturer
MainPointe Pharmaceuticals, LLC | Mission Pharmacal
Effective date
2020-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:50

Label at a glance#

ProductDR SMITHS DIAPER
Active ingredientZINC OXIDE
Label structure12 sections

Storage and handling

Store between 15 0 and 30 0 C (59 0 and 86 0 F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 10%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product, avoid contact with the eyes.

OTC - STOP USE SECTION

See a doctor if condition lasts more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 diapers may be prolonged.

Storage and Handling

STORAGE AND HANDLING SECTION

Store between 15 0 and 30 0 C (59 0 and 86 0 F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide

OTHER SAFETY INFORMATION

To report a serious adverse event of obtain product information, call (502)709-7544.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 oz. Carton3 oz. Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1494206Dr. Smith's Diaper Ointment 10 % Topical OintmentPSN1
199099zinc oxide 10 % Topical OintmentPSN1
1494206zinc oxide 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]SBD1
199099zinc oxide 0.1 MG/MG Topical OintmentSCD1
1494206Dr. Smith's Adult Barrier 10 % Topical OintmentSY1
1494206Dr. Smith's Diaper Ointment 10 % Topical OintmentSY1
1494206Dr. Smith's Diaper Rash 0.1 MG/MG Topical OintmentSY1
199099zinc oxide 10 % Topical OintmentSY1
199099ZNO 0.1 MG/MG Topical OintmentSY1
1494206ZNO 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]SY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71269-006-032022-01-28C16284748780-1d6a99b39-87fa-a426-e053-dadaa90af4c2Dr. Smith's Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71269-006-03DR SMITHS DIAPER85 g in 1 TUBEOINTMENT851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71269-006DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MAINPOINTE PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20200225_9f5882f7-d942-5b70-e053-2995a90aefcb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71269-006-03GM - Gram71269-00636a525f7-8fd3-454f-9001-70794039f91b12021-09-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71269-00671269-006-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
OLIVE OIL6UYK2W1W1EIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
THYMOL IODIDEA51HJM3XSUIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9eb95f61-0773-42a1-80d3-f9a74f6292b89f5882f7-d942-5b70-e053-2995a90aefcb2026-08-28WarningsExact identifier
spl set id: 9f5882f7-d942-5b70-e053-2995a90aefcb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.