FDA.reportPublic FDA data

PETROLATUM

Manufacturer
Dynarex Corporation | Galentic PharmaIndia Private Limited | Amar Remedies Limited
Effective date
2012-12-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:33:58

Label at a glance#

ProductPETROLATUM
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor * cuts * scrapes * burns Temporarily helps protect and helps relieve chapped and cracked skin and lips Helps prevent and protect from the drying effects of wind and cold weather Helps prevent and protect chaffed skin or minor skin irritations associated with diaper rash With each diaper change, especially at bed time when exposur...

Dosage and administration

Change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                            Purpose

White Petrolatum 100%                 Skin Protectant            

Uses:

OTC - PURPOSE SECTION

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and helps relieve chapped and cracked skin and lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect chaffed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bed time when exposure to wet diapers may be prolonged.

Warnings:

WARNINGS SECTION

For external use only.

When using this product:

OTC - WHEN USING SECTION

Do not get in eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • symptoms last more than 7 days or clear up and occur in a few days.

Do not use on:

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • animal bites
  • serious burns

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

  • Change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply as needed

Other information:

SPL UNCLASSIFIED SECTION

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

Indications and Usage

INDICATIONS & USAGE SECTION

Skin Protectant

Principal Display Panel:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Petrolatum JellyPetrolatum Jelly

Petrolatum_Jelly.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN7
204754petrolatum 1 MG/MG Topical OintmentSCD7
204754petrolatum 100 % Topical JellySY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-400-012019-11-27C16284748780-19855d018-ea20-cd31-e053-dbdaa90ab51aPetrolatum Jelly
67777-400-022019-11-27C16284748780-19855d018-ea20-cd31-e053-dbdaa90ab51aPetrolatum Jelly
67777-400-032019-11-27C16284748780-19855d018-ea20-cd31-e053-dbdaa90ab51aPetrolatum Jelly
67777-400-042019-11-27C16284748780-19855d018-ea20-cd31-e053-dbdaa90ab51aPetrolatum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-400-01PETROLATUM12 in 1 CASEJELLY127
67777-400-01PETROLATUM6 in 1 BOXJELLY67
67777-400-02PETROLATUM6 in 1 BOXJELLY67
67777-400-02PETROLATUM12 in 1 CASEJELLY127
67777-400-03PETROLATUM6 in 1 BOXJELLY67
67777-400-03PETROLATUM12 in 1 CASEJELLY127
67777-400-04PETROLATUM12 in 1 CASEJELLY127
67777-400-04PETROLATUM425.2 g in 1 JARJELLY425.27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-400PETROLATUM JELLY [DYNAREX CORPORATION]7Legacy NDC, 8 package rows20121214_dfc69165-44a8-4d5e-bfeb-6f2d8d207e16.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U7
PETROLATUMACTIVE MOIETY4T6H12BN9U7

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-40067777-400-01, 67777-400-02, 67777-400-03, 67777-400-04

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
b582c7fd-fb35-42a1-a897-3bb219d19851dfc69165-44a8-4d5e-bfeb-6f2d8d207e162012-12-13WarningsExact identifier
spl id: b582c7fd-fb35-42a1-a897-3bb219d19851
spl set id: dfc69165-44a8-4d5e-bfeb-6f2d8d207e16

Reported adverse events (FAERS/openFDA)#

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