FDA.reportPublic FDA data

Active ingredient

Manufacturer
Apollo Health and Beauty Care
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:42

Label at a glance#

ProductCVS
Active ingredientPETROLATUM
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness.

Dosage and administration

- Change wet and soiled diapers promptly, cleanse the diaper area, and 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 41%

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 protect from wetness.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

do not get in eyes.

Stop use and ask a doctor if

OTC - WHEN USING 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, and 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, Ceresin, Lanolin Alcohol, Glycerin, Bisabolol, Panthenol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baby OintmentBaby Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
725145petrolatum 41 % Topical OintmentPSN2
725145petrolatum 0.41 MG/MG Topical OintmentSCD2
725145petrolatum 41 % Topical OintmentSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428282311GTIN-13: 0050428282311
EAN-13: 0050428282311
GTIN-12: 050428282311
UPC-A: 050428282311
GTIN storage (14 digits): 00050428282311		06-27063V1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-178-14CVS397 g in 1 JAROINTMENT3972

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-17863148-178-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PANTHENOLWV9CM0O67ZIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UACTIB
GLYCERINPDC6A3C0OXIACT
BISABOLOL24WE03BX2TIACT
MINERAL OILT5L8T28FGPIACT
LANOLIN ALCOHOL884C3FA9HEIACT

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
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
ndc (package): 63148-178-14
ndc (product): 63148-178
ndc11 (package): 63148017814
spl id: 50b458dd-fabe-9a2d-e063-6294a90a3646
spl set id: 47d2b9be-91ad-e9e2-e063-6294a90ac29f

Reported adverse events (FAERS/openFDA)#

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