FDA.reportPublic FDA data

PETROLEUM

Manufacturer
Cardinal Health
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:26

Label at a glance#

ProductPETROLEUM
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

temporarily protects minor * cuts * scrapes * burns temporarily protects and helps relieve chapped and cracked skin or lips 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, 100%  w/w)                    

Purpose

OTC - PURPOSE SECTION

Skin Protectant


Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external use only.

Do not use

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 - STOP USE SECTION

  • condition worsens
  • condition lasts more than 7 days or clears up and occurs 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

None

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 59 Deg F - 86 Deg F (15 - 30 Deg C)
  • Avoid excessive heat.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Petroleum Jelly

White Petrolatum 100%

Cardinal Health

NDC 63517-211-05


Net Wt 3.25 oz (92.14g)



wUntitled.jpg
wUntitled.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN3
204754petrolatum 1 MG/MG Topical OintmentSCD3
204754petrolatum 100 % Topical JellySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63517-211-012024-01-30C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-032024-01-30C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-052024-01-30C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-102024-01-30C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-012022-01-21C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-032022-01-21C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-052022-01-21C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-102022-01-21C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-012020-01-31C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-032020-01-31C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-052020-01-31C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly
63517-211-102020-01-31C16284748780-19d75b9d0-2275-f424-e053-dadaa90a57cePetrolatum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-211-01PETROLEUM6 in 1 CASEJELLY63
63517-211-01PETROLEUM144 in 1 BOXJELLY1443
63517-211-03PETROLEUM100 in 1 CASEJELLY1003
63517-211-03PETROLEUM28.3 g in 1 TUBEJELLY28.33
63517-211-05PETROLEUM100 in 1 CASEJELLY1003
63517-211-05PETROLEUM92.14 g in 1 TUBEJELLY92.143
63517-211-10PETROLEUM284 g in 1 TUBEJELLY2843
63517-211-10PETROLEUM24 in 1 CASEJELLY243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-211PETROLEUM (PETROLATUM) JELLY [CARDINAL HEALTH]3Legacy NDC, 8 package rows20221213_f04337fb-6245-47f2-b2e6-7974feb3f644.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63517-21163517-211-01, 63517-211-03, 63517-211-05, 63517-211-10

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
efa7d0a1-51e5-ec2d-e053-2995a90a840df04337fb-6245-47f2-b2e6-7974feb3f6442022-12-12WarningsExact identifier
spl id: efa7d0a1-51e5-ec2d-e053-2995a90a840d
spl set id: f04337fb-6245-47f2-b2e6-7974feb3f644

Reported adverse events (FAERS/openFDA)#

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