FDA.reportPublic FDA data

PURE PETROLEUM

Manufacturer
Shield Line LLC
Effective date
2021-02-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:33

Label at a glance#

ProductPURE PETROLEUM
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

for the temporary protection of minor cuts, scrapes, burns and sunburn helps to temporarily protect chafed , chapped , cracked or windburned skin and lips

Dosage and administration

apply as needed

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

  • for the temporary protection of minor cuts, scrapes, burns and sunburn
  • helps to temporarily protect chafed , chapped , cracked or windburned skin and lips

Warnings: FOR EXTERNAL USE ONLY

WARNINGS SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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 clean up and occur again in a few days

Keep out of reach of childen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • if swalloed , get medical help or contact a Proison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature

Inactive Ingradients

INACTIVE INGREDIENT SECTION

None

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal DisplayPrincipal Display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN3
204754petrolatum 1 MG/MG Topical OintmentSCD3
204754petrolatum 100 % Topical JellySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-0202-22022-07-29C16284748780-1ba0f9c33-29b0-a910-e053-dadaa90a0b8535c163e6-ae58-2791-e054-00144ff8d46c
52410-0202-42022-07-29C16284748780-1ba0f9c33-29b0-a910-e053-dadaa90a0b8535c163e6-ae58-2791-e054-00144ff8d46c
52410-0202-22021-02-25C16284748780-1ba0f9c33-29b0-a910-e053-dadaa90a0b8535c163e6-ae58-2791-e054-00144ff8d46c
52410-0202-42021-02-25C16284748780-1ba0f9c33-29b0-a910-e053-dadaa90a0b8535c163e6-ae58-2791-e054-00144ff8d46c
52410-0202-22021-01-29C16284748780-1ba0f9c33-29b0-a910-e053-dadaa90a0b8535c163e6-ae58-2791-e054-00144ff8d46c
52410-0202-42021-01-29C16284748780-1ba0f9c33-29b0-a910-e053-dadaa90a0b8535c163e6-ae58-2791-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-0202-2PURE PETROLEUM226 g in 1 JARJELLY2263
52410-0202-4PURE PETROLEUM368 g in 1 JARJELLY3683

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-0202PURE PETROLEUM (PETROLATUM) JELLY [SHIELD LINE LLC]3Legacy NDC, 2 package rows20210226_35c163e6-ae58-2791-e054-00144ff8d46c.zip

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
52410-020252410-0202-2, 52410-0202-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bc18f329-eae3-6ea1-e053-2a95a90a963635c163e6-ae58-2791-e054-00144ff8d46c2021-02-24WarningsExact identifier
spl id: bc18f329-eae3-6ea1-e053-2a95a90a9636
spl set id: 35c163e6-ae58-2791-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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