FDA.reportPublic FDA data

White Petrolatum USP Ointment

Manufacturer
GERITREX LLC
Effective date
2018-10-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 22:57:02

Label at a glance#

ProductWhite Petrolatum
Active ingredientPETROLATUM
Label structure7 sections

Indications and uses

Temporarily protects minor: cuts scrapes burns Temporarily protects and helps chapped lips and cracked skin

Dosage and administration

Cleanse area with mild soap and water. Apply White Petrolatum liberally.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • Temporarily protects and helps chapped lips and cracked skin

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if:

OTC - STOP USE SECTION

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

When using this product: avoid contact with eyes

SPL UNCLASSIFIED SECTION

Don't not use on:

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

In case of deep puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or infection occurs, discontinue use and consult a physician.

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

Cleanse area with mild soap and water. Apply White Petrolatum liberally.

Other information

OTHER SAFETY INFORMATION

  • Avoid excessive heat and humidity
  • Store at 15-30°C (59-86°F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28g label28g label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN9
204754petrolatum 1 MG/MG Topical OintmentSCD9
204754petrolatum 100 % Topical JellySY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-597-052020-01-31C16284748780-19d75b9d0-64e4-f424-e053-dadaa90a57ceWhite Petrolatum USP Ointment
54162-597-282020-01-31C16284748780-19d75b9d0-64e4-f424-e053-dadaa90a57ceWhite Petrolatum USP Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-597-05White Petrolatum5 g in 1 POUCHOINTMENT59
54162-597-28White Petrolatum28 g in 1 TUBEOINTMENT289

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-597WHITE PETROLATUM OINTMENT [GERITREX LLC]9Legacy NDC, 2 package rows20181018_9d2dbef6-f7cf-46ed-b991-d66f6412e2e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-597-05GM - Gram54162-597360a646e-88c3-4350-835a-fa89335811e512015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U4
PETROLATUMACTIVE MOIETY4T6H12BN9U4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U4

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
54162-59754162-597-28, 54162-597-05

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
PETROLATUM4T6H12BN9UACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates

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
dff5f8e4-a173-4ea3-abb0-a025fb30b9a49d2dbef6-f7cf-46ed-b991-d66f6412e2e72018-10-12WarningsExact identifier
spl id: dff5f8e4-a173-4ea3-abb0-a025fb30b9a4
spl set id: 9d2dbef6-f7cf-46ed-b991-d66f6412e2e7

Reported adverse events (FAERS/openFDA)#

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