FDA.reportPublic FDA data

SKIN PROTECTANT PETROLATUM OINTMENT

Manufacturer
Nationwide Pharmaceutical, LLC
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:39

Label at a glance#

ProductSKIN PROTECTANT PETROLATUM
Active ingredientPetrolatum
Label structure10 sections

Indications and uses

Temporarily protects minor cuts, scrapes, and burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect skin from drying effects of wind and cold weather.

Dosage and administration

Apply as needed.

Storage and handling

Store at room temperature (59°-86°F) Do not use if inner seal is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 44.28%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor cuts, scrapes, and burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps protect skin from drying effects of wind and cold weather.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes In case of contact, flush thoroughly with water.

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
  • broken skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature (59°-86°F)
  • Do not use if inner seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, microcrystalline wax, mineral oil, and polysorbate 60

Questions or comments?

OTC - QUESTIONS SECTION

1-800-697-3329

PRINCIPAL DISPLAY PANEL - 454 GM Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69375-0004-54

Nationwide
Pharmaceutical

Skin Protectant
Petrolatum Ointment

For dry, cracked or irritated skin

454 GM (16 OZ)

PRINCIPAL DISPLAY PANEL - 454 GM Jar Label
PRINCIPAL DISPLAY PANEL - 454 GM Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373226petrolatum 44 % Topical OintmentPSN1
1373226petrolatum 0.44 MG/MG Topical OintmentSCD1
1373226petrolatum 44 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69375-004-542022-07-29C16284748780-1e4f33bdf-abe2-d8a0-e053-dadaa90a6e4eSKIN PROTECTANT PETROLATUM OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69375-004-54SKIN PROTECTANT PETROLATUM454 g in 1 JAROINTMENT4541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69375-004SKIN PROTECTANT PETROLATUM (PETROLATUM) OINTMENT [NATIONWIDE PHARMACEUTICAL, LLC]1Legacy NDC, 1 package rows20210301_e38d1050-df08-4b18-b4e4-11688ca2bedc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69375-004-54GM - Gram69375-004ad5d5bf9-9968-4f21-b387-44a5d2ee288112021-05-05

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69375-00469375-004-54

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
Petrolatum4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT

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
21aaf4fe-9205-4f02-90c5-e00982dba6e5e38d1050-df08-4b18-b4e4-11688ca2bedc2021-02-23WarningsExact identifier
spl id: 21aaf4fe-9205-4f02-90c5-e00982dba6e5
spl set id: e38d1050-df08-4b18-b4e4-11688ca2bedc

Reported adverse events (FAERS/openFDA)#

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