FDA.reportPublic FDA data

UNIVERSAL BABY FRESH SCENT PETROLEUM

Manufacturer
Universal Distribution Center LLC
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:31

Label at a glance#

ProductUNIVERSAL BABY FRESH SCENT PETROLEUM
Active ingredientPETROLATUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

White Petrolatum USP (99.9 %)

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For External Use Only.

OTC - DO NOT USE SECTION

Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask doctor if condition worsens or does not improve within 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply product as liberally, as often as necessary.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Universal Baby fresh Scent Petroleum
Jelly
Net Wt. 13 OZ (368 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148414petrolatum 99.9 % Topical GelPSN3
1148414petrolatum 0.999 MG/MG Topical GelSCD3
1148414petrolatum 99.9 % Topical JellySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-101-01UNIVERSAL BABY FRESH SCENT PETROLEUM170 g in 1 JARJELLY1703
52000-101-02UNIVERSAL BABY FRESH SCENT PETROLEUM226 g in 1 JARJELLY2263
52000-101-03UNIVERSAL BABY FRESH SCENT PETROLEUM368 g in 1 JARJELLY3683
52000-101-04UNIVERSAL BABY FRESH SCENT PETROLEUM510 g in 1 JARJELLY5103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-101UNIVERSAL BABY FRESH SCENT PETROLEUM (WHITE PETROLEUM) JELLY [UNIVERSAL DISTRIBUTION CENTER LLC]3Current NDC, Legacy NDC, 4 package rows20231121_b6e0ddb8-3761-482a-83d0-15d612d142eb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-10152000-101-01, 52000-101-02, 52000-101-03, 52000-101-04

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
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCb6e0ddb8-3761-482a-83d0-15d612d142eb2023-11-15WarningsExact identifier
ndc (package): 52000-101-04
ndc (package): 52000-101-01
ndc (package): 52000-101-03
ndc (package): 52000-101-02
ndc (product): 52000-101
ndc11 (package): 52000010103
ndc11 (package): 52000010104
ndc11 (package): 52000010101
ndc11 (package): 52000010102
spl id: e7711f73-4588-4f11-adca-837a66453de6
spl set id: b6e0ddb8-3761-482a-83d0-15d612d142eb

Reported adverse events (FAERS/openFDA)#

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