FDA.reportPublic FDA data

Pure Petroleum

Manufacturer
Pan Aromas LLC | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2012-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:07

Label at a glance#

ProductPure Petroleum
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

For the temporary protection of minor cuts, scraps, burns and sunburn. Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Dosage and administration

Apply liberally, as often as necessary.

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, scraps, burns and sunburn.
  • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

over deep or puncture wounds, infections or lacerations. Ask a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens or does not improve after 7 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

Apply liberally, as often as necessary.

Inactive ingredients

INACTIVE INGREDIENT SECTION

None

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURE PETROLEUM JELLY
NET WT. 8 OZ (226 g)

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN1
204754petrolatum 1 MG/MG Topical OintmentSCD1
204754petrolatum 100 % Topical JellySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50346-001-012020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-022020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-032020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-042020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-052020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-062020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-072020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-082020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY
50346-001-092020-01-31C16284748780-19d75b9d1-1b0f-f424-e053-dadaa90a57cePURE PETROLEUM JELLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50346-001-01Pure Petroleum100 g in 1 JARJELLY1001
50346-001-02Pure Petroleum113 g in 1 JARJELLY1131
50346-001-03Pure Petroleum142 g in 1 JARJELLY1421
50346-001-04Pure Petroleum170 g in 1 JARJELLY1701
50346-001-05Pure Petroleum198 g in 1 JARJELLY1981
50346-001-06Pure Petroleum226 g in 1 JARJELLY2261
50346-001-07Pure Petroleum255 g in 1 JARJELLY2551
50346-001-08Pure Petroleum283 g in 1 JARJELLY2831
50346-001-09Pure Petroleum368 g in 1 JARJELLY3681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50346-001PURE PETROLEUM (WHITE PETROLEUM) JELLY [PAN AROMAS LLC]1Legacy NDC, 9 package rows20120530_eeaebd3b-2b23-4bf1-b130-93e1cf4591cc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

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
50346-00150346-001-01, 50346-001-02, 50346-001-03, 50346-001-04, 50346-001-05, 50346-001-06, 50346-001-07, 50346-001-08, 50346-001-09

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
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
f0a92676-2545-457f-80c3-d2e24b83653deeaebd3b-2b23-4bf1-b130-93e1cf4591cc2012-05-26WarningsExact identifier
spl id: f0a92676-2545-457f-80c3-d2e24b83653d
spl set id: eeaebd3b-2b23-4bf1-b130-93e1cf4591cc

Reported adverse events (FAERS/openFDA)#

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