FDA.reportPublic FDA data

DiaperDerm Diaper Rash Cream

Manufacturer
Diaperderm Inc
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:57

Label at a glance#

ProductDiaperDerm Diaper Rash
Active ingredientZINC OXIDE
Label structure6 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product,

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens or symptoms last more than 7 days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lanolin, petrolatum, vitamin A, vitamin D3

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1191136zinc oxide 5 % Rectal CreamPSN3
1191136zinc oxide 50 MG/ML Rectal CreamSCD3
1191136zinc oxide 5 % Rectal CreamSY3
1191136ZNO 50 MG/ML Rectal CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80651-093-00DiaperDerm Diaper Rash236 mL in 1 JARCREAM2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80651-093DIAPERDERM DIAPER RASH (ZINC OXIDE) CREAM [DIAPERDERM INC]3Current NDC, Legacy NDC, 1 package rows20231106_4e1fce3e-c2b7-42da-9953-1dbb13e2467c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80651-09380651-093-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
VITAMIN A81G40H8B0TIACT
CHOLECALCIFEROL1C6V77QF41IACT
ZINC OXIDESOI2LOH54ZACTIM

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
DiaperDerm Diaper RashZINC OXIDEDiaperderm Inc4e1fce3e-c2b7-42da-9953-1dbb13e2467c2023-11-06WarningsExact identifier
ndc (package): 80651-093-00
ndc (product): 80651-093
ndc11 (package): 80651009300
spl id: 09762412-1b73-516e-e063-6294a90a6753
spl set id: 4e1fce3e-c2b7-42da-9953-1dbb13e2467c

Reported adverse events (FAERS/openFDA)#

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