FDA.reportPublic FDA data

Diaper Rash Ointment

Manufacturer
Universal Distribution Centre LLC
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:07

Label at a glance#

ProductDiaper Rash skin protectant
Active ingredientLANOLIN, PETROLATUM
Label structure8 sections

Indications and uses

helps treat and prevent diaper rash temporarily protects minor: cuts scrapes burns temporarily protects and helps relieve chapped, chafed or cracked skin and lips protect chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

for skin protectant use apply as needed for diaper rash use: 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

Storage and handling

store between 20°C to 25 °C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lanolin 15.5%Diaper rash ointment
Petrolatum 53.4%Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
  • protect 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

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protectant use apply as needed
  • for diaper rash use:
    • 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

Other information

STORAGE AND HANDLING SECTION

store between 20°C to 25 °C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

PRINCIPAL DISPLAY PANEL - 35.4g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-073-022025-07-29C16284748780-13b156c62-2606-fb37-e063-e6dba90a4e07Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-073-01Diaper Rash skin protectant35.4 g in 1 TUBEOINTMENT35.44
52000-073-02Diaper Rash skin protectant1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-073DIAPER RASH SKIN PROTECTANT (LANOLIN AND PETROLATUM) OINTMENT [UNIVERSAL DISTRIBUTION CENTRE LLC]4Current NDC, Legacy NDC, 2 package rows20241212_b9bbc5ac-18a9-99ec-e053-2995a90a9a76.zip

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
52000-07352000-073-01, 52000-073-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
COD LIVER OILBBL281NWFGIACT
LIGHT MINERAL OILN6K5787QVPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PARAFFINI9O0E3H2ZEIACT
LANOLIN7EV65EAW6HACTIB
PETROLATUM4T6H12BN9UACTIB

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
ndc (product): 52000-073
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
ndc (product): 52000-073
2f1f730b-304d-4168-9564-701bf2629944b9bbc5ac-18a9-99ec-e053-2995a90a9a762024-12-04WarningsExact identifier
spl id: 2f1f730b-304d-4168-9564-701bf2629944
spl set id: b9bbc5ac-18a9-99ec-e053-2995a90a9a76

Reported adverse events (FAERS/openFDA)#

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