FDA.reportPublic FDA data

Pharmadel Petroleum Jelly 100%

Manufacturer
Pharmadel LLC
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:41:58

Label at a glance#

ProductPharmadel Petroleum Jelly 100%
Active ingredientWHITE PETROLATUM
Label structure7 sections

Indications and uses

Helps protect minor cuts, scrapes and burns chapped or cracked skin from the drying effects of wind and cold weather from wetness

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient Purpose
White Petrolatum 100%...........Skin protectant

Uses

INDICATIONS & USAGE SECTION

Helps protect

  • minor cuts, scrapes and burns
  • chapped or cracked skin
  • from the drying effects of wind and cold weather
  • from wetness

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes.

See as a doctor if

OTC - ASK DOCTOR SECTION

condition lasts more than 7 days.

Keep put 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 as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

None

Dist. by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

Questions?

+1-866-359-3478

Made in India

*This product is not manufactured or distributed by Unilever, owner of the registered trademark Vaseline®

Store between 59-86°F (15-30°C)

DO NOT USE if clear seal over

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP PETROLEUM JELLYPDP PETROLEUM JELLY

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-424PHARMADEL PETROLEUM JELLY 100% (WHITE PETROLATUM) JELLY [PHARMADEL LLC]4Unmatched20250123_1e65f49c-c658-073f-e063-6294a90a4450.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
55758-42455758-424-04

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
437f93d5-d592-6b3a-e063-6294a90ac2681e65f49c-c658-073f-e063-6294a90a44502025-11-13WarningsExact identifier
spl set id: 1e65f49c-c658-073f-e063-6294a90a4450

Reported adverse events (FAERS/openFDA)#

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