FDA.reportPublic FDA data

CVS Health Diaper Rash

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:37

Label at a glance#

ProductCVS Health Diaper Rash
Active ingredientZINC OXIDE
Label structure10 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 cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (13%)

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

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few 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 cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

  • store at 20° to 25°C (68° to 77°F)
  • protect from freezing
  • may stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil (Paraffinium Liquidum), Petrolatum, Beeswax, Sorbitan Sesquioleate, Glycerin, Microcrystalline Wax, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Magnesium Sulfate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Potassium Hydroxide.

Principal Display Panel – Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS

Health ®

Compare to the active
ingredient in Desitin ®Daily
Defense Diaper Rash Cream*

Cream

Diaper
Rash
Cream

ZINC OXIDE 13%

Skin protectant

Daily use for
diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)

Principal Display Panel – Box Label
Principal Display Panel – Box Label

Principal Display Panel – Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS

Health ®

Cream

Diaper
Rash
Cream

ZINC OXIDE 13%

Skin protectant

Daily use for
diaper rash

Fast acting

Paraben Free

Fragrance free

NET WT 4 OZ (113 g)

Principal Display Panel – Tube Label
Principal Display Panel – Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
349404zinc oxide 13 % Topical CreamPSN2
349404zinc oxide 130 MG/ML Topical CreamSCD2
349404zinc oxide 13 % Topical CreamSY2
349404ZNO 130 MG/ML Topical CreamSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-449-04CVS Health Diaper Rash1 in 1 BOXCREAM12
66902-449-04CVS Health Diaper Rash113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-449CVS HEALTH DIAPER RASH (ZINC OXIDE) CREAM [NATURAL ESSENTIALS, INC.]2Legacy NDC, 2 package rows20241004_e2a5270e-7c16-47bc-bd19-5652049b4dfd.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-44966902-449-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WHITE WAX7G1J5DA97FIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
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
2370a0e2-9e94-d47c-e063-6394a90a4f09e2a5270e-7c16-47bc-bd19-5652049b4dfd2024-10-01WarningsExact identifier
spl id: 2370a0e2-9e94-d47c-e063-6394a90a4f09
spl set id: e2a5270e-7c16-47bc-bd19-5652049b4dfd

Reported adverse events (FAERS/openFDA)#

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