FDA.reportPublic FDA data

Petroleum

Manufacturer
Vi-Jon, LLC
Effective date
2021-09-01
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 22:36:59

Label at a glance#

ProductPetroleum
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply product liberally as often as necessary, with each diaper change, and 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

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out 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

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • symptoms longer than 7 days or clear up and occur again within a few 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

  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredient

INACTIVE INGREDIENT SECTION

fragrance

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Petroleum Jelly

NET WT. 13 OZ (368 g)

image descriptionimage description

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
11344-51911344-519-18, 11344-519-96, 11344-519-27

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
1a61411f-e725-4984-9d74-4411da8703fd3dd47d9d-ecd2-4d5c-b2b3-3402ce06df3c2022-12-15WarningsExact identifier
spl set id: 3dd47d9d-ecd2-4d5c-b2b3-3402ce06df3c

Reported adverse events (FAERS/openFDA)#

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