FDA.reportPublic FDA data

ProCure Petroleum

Manufacturer
Twin Med LLC
Effective date
2025-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:45

Label at a glance#

ProductProCure Petroleum
Active ingredientWHITE PETROLATUM
Label structure7 sections

Indications and uses

Temporarily protects minor: cuts, scrapes, burns Temporarily protects chafed, chapped or cracked skin Helps protect against the drying effects of wind and cold weather Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

Directions As a skin protectant: apply as needed For diaper rash : Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply jelly 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

White Petrolatum USP, 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor: cuts, scrapes, burns
  • Temporarily protects chafed, chapped or cracked skin
  • Helps protect against the drying effects of wind and cold weather
  • Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

Warnings

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product do not get into the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

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

Directions

  • As a skin protectant: apply as needed
  • For diaper rash: Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply jelly liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

INACTIVE INGREDIENT SECTION

None

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCPJ13 ImagePCPJ13 Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN2
204754petrolatum 1 MG/MG Topical OintmentSCD2
204754petrolatum 100 % Topical JellySY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130816516015816GTIN-13: 0816516015816
EAN-13: 0816516015816
GTIN-12: 816516015816
UPC-A: 816516015816
GTIN storage (14 digits): 00816516015816		PCPJ13 Image.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-049-02ProCure Petroleum56.6 g in 1 TUBEJELLY56.62
55681-049-05ProCure Petroleum5 g in 1 PACKETJELLY52
55681-049-13ProCure Petroleum369 g in 1 JARJELLY3692
55681-049-14ProCure Petroleum144 in 1 CARTONJELLY1442

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-04955681-049-02, 55681-049-13, 55681-049-05, 55681-049-14

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WHITE PETROLATUMB6E5W8RQJ4ACTIB

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
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
ndc (package): 55681-049-13
ndc (package): 55681-049-05
ndc (package): 55681-049-02
ndc (package): 55681-049-14
ndc (product): 55681-049
ndc11 (package): 55681004914
ndc11 (package): 55681004905
ndc11 (package): 55681004902
ndc11 (package): 55681004913
spl id: 42c4f1ea-a4a9-2c44-e063-6294a90a18d2
spl set id: 3eddf0e7-8e9d-a311-e063-6394a90ad156

Reported adverse events (FAERS/openFDA)#

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