FDA.reportPublic FDA data

Petrolatum

Manufacturer
Greenbrier International, Inc.
Effective date
2019-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:33

Label at a glance#

ProductPetrolatum
Active ingredientPetrolatum
Label structure7 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

White Petrolatum USP (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.

Do not use on deep puncture wounds, animal bites and serious burns.

OTC - WHEN USING SECTION

When using this product, do not get into eyes.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • condition worsens,
  • symptoms last more than 7 days
  • 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

Apply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua), glycerine, glyceryl monostearate, PEG 100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Principal Display Panel - Petroleum Jelly Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

Vitamin E Enriched

Creamy
PETROLEUM
JELLY

Skin Softener

For Dry Skin

Absorbs Quickly

Compare to active ingredient of
Vaseline® Deep Moisture™

Net Wt 3 oz (85g)

NDC # 33992-0499-1

Principal Display Panel - Petroleum Jelly Tube Label
Principal Display Panel - Petroleum Jelly Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043075petrolatum 30 % Topical CreamPSN2
1043075petrolatum 300 MG/ML Topical CreamSCD2
1043075petrolatum 30 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-0499-1Petrolatum85 g in 1 TUBECREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-0499PETROLATUM CREAM [GREENBRIER INTERNATIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20190214_b8832ee7-3e13-456b-b301-dad7473a032b.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-049933992-0499-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Petrolatum4T6H12BN9UACTIB
Water059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
TROLAMINE9O3K93S3TKIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHYLENE GLYCOL3P5SU53360IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT

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
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
ndc (package): 33992-0499-1
ndc (product): 33992-0499
ndc11 (package): 33992049901
spl id: 41de449c-fada-455f-a565-c8a54589a93c
spl set id: b8832ee7-3e13-456b-b301-dad7473a032b

Reported adverse events (FAERS/openFDA)#

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