FDA.reportPublic FDA data

Diaper Cream

Manufacturer
Private Label Select Ltd CO
Effective date
2019-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:38

Label at a glance#

ProductDiaper Cream
Active ingredientMENTHOL, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

MIKESRX Dosage n Admin

DOSAGE & ADMINISTRATION SECTION

MIKERX Dosage AdminMIKERX Dosage Admin

MIKESRX Inactive Ingredients

INACTIVE INGREDIENT SECTION

MIKESRX InactiveMIKESRX Inactive

MIKESRX Indications Usage

INDICATIONS & USAGE SECTION

MIKESRX Indictn n UsageMIKESRX Indictn n Usage

MIKESRX OTC-Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

MIESRX Active IngredientsMIESRX Active Ingredients

MIKESRX Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

MIKESRX Keep out of reachMIKESRX Keep out of reach

MIKESRX Purpose

OTC - PURPOSE SECTION

MIKESRX PurposeMIKESRX Purpose

MIKESRX Warnings

WARNINGS SECTION

MIKESRX WarningsMIKESRX Warnings

MikesRX Diaper Rash Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MikesRX Diaper Rash OintmentMikesRX Diaper Rash Ointment

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
62932-157-212021-01-29C16284748780-1ba0f9c33-12ea-a910-e053-dadaa90a0b85MikesRXment Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62932-157-21Diaper Cream113 g in 1 TUBEOINTMENT1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62932-157DIAPER CREAM OINTMENT [PRIVATE LABEL SELECT LTD CO]1Legacy NDC, 1 package rows20190611_8905aa22-5787-d756-e053-2a95a90add84.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62932-15762932-157-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
MENTHOLL7T10EIP3AACTIB
JOJOBA OIL724GKU717MIACT
LANOLIN7EV65EAW6HIACT
ZINC OXIDESOI2LOH54ZACTIB
COCONUT OILQ9L0O73W7LIACT
SHEA BUTTERK49155WL9YIACT
CASTOR OILD5340Y2I9GIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT

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
8905aa22-5788-d756-e053-2a95a90add848905aa22-5787-d756-e053-2a95a90add842019-05-16WarningsExact identifier
spl id: 8905aa22-5788-d756-e053-2a95a90add84
spl set id: 8905aa22-5787-d756-e053-2a95a90add84

Reported adverse events (FAERS/openFDA)#

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