FDA.reportPublic FDA data

PETROLEUM jelly

Manufacturer
Universal Distribution Center LLC
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:42:10

Label at a glance#

ProductPETROLEUM jelly
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

• temporarily protects minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped or cracked skin • helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 30%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• temporarily protects minor: • cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked skin
• helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on • deep puncture wounds • animal bites • serious burns

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.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

water (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, polysorbate 80, laureth-20, BHT, methylparaben, propylparaben, dimethicone, tocopherol.

SPL UNCLASSIFIED SECTION

NEW

for Dry Skin

ABSORBS QUICKLY

Moisturizing

Replenish Skin Balance

Compare to the active ingredient of Vaseline® ​Petroleum Jelly Cream*

​Helps restore skin's natural moisture

Distributed by:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
www.universaldc.com

Made in P.R.C

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jelly-123Jelly-123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037285petrolatum 30 % Topical GelPSN2
1037285petrolatum 0.3 MG/MG Topical GelSCD2
1037285petrolatum 30 % Topical GelSY2
1037285petrolatum 30 % Topical JellySY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-123-34PETROLEUM jelly133 mL in 1 TUBECREAM1332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-123PETROLEUM JELLY (PETROLATUM) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20241212_eaaf95d7-df80-407e-b784-4e42a89d64e5.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-12352000-123-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-206SU0SC83AHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
TOCOPHEROLR0ZB2556P8IACT

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
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
ndc (package): 52000-123-34
ndc (product): 52000-123
ndc11 (package): 52000012334
spl id: 1ff1b029-64c1-4240-9800-61341fdb4db4
spl set id: eaaf95d7-df80-407e-b784-4e42a89d64e5

Reported adverse events (FAERS/openFDA)#

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