FDA.reportPublic FDA data

PETROLEUM

Manufacturer
PRIMAL ELEMENTS
Effective date
2023-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:24:13

Label at a glance#

ProductPETROLEUM
Active ingredientWHITE PETROLATUM
Label structure9 sections

Dosage and administration

Apply liberally, as often as necessary.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum (100%)

Purpose

OTC - PURPOSE SECTION

Skin protectant

Use

DOSAGE & ADMINISTRATION SECTION

  • Helps treat and prevent diaper rash
  • Petroleum jelly restores smooth and healthy skin
  • Helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind
  • For the temporary protection of minor cuts, scrapes, burns and sunburn

Warnings:

WARNINGS SECTION

For external use only

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

INDICATIONS & USAGE SECTION

Apply liberally, as often as necessary.

Inactive

INACTIVE INGREDIENT SECTION

fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
80801-10480801-104-01

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
079433c0-8dff-946c-e063-6394a90a7898079433c0-8dfe-946c-e063-6394a90a78982023-10-01WarningsExact identifier
spl id: 079433c0-8dff-946c-e063-6394a90a7898
spl set id: 079433c0-8dfe-946c-e063-6394a90a7898

Reported adverse events (FAERS/openFDA)#

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