FDA.reportPublic FDA data

PETROLATUM

Manufacturer
Dynarex Corporation | Choice Laboratories | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2013-04-09
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-05-31 22:35:10

Label at a glance#

ProductPETROLATUM
Active ingredientPETROLATUM
Label structure10 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:

INDICATIONS & USAGE 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 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

petrolatum_jelly.jpg

white_petrolatumwhite_petrolatum

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN14
204754petrolatum 1 MG/MG Topical OintmentSCD14
204754petrolatum 100 % Topical JellySY14

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-211-012020-01-31C16284748780-19d75b9d0-6805-f424-e053-dadaa90a57ceWhite Petrolatum
67777-211-022020-01-31C16284748780-19d75b9d0-6805-f424-e053-dadaa90a57ceWhite Petrolatum
67777-211-032020-01-31C16284748780-19d75b9d0-6805-f424-e053-dadaa90a57ceWhite Petrolatum
67777-211-072020-01-31C16284748780-19d75b9d0-6805-f424-e053-dadaa90a57ceWhite Petrolatum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-211-01PETROLATUM144 in 1 BOXJELLY14414
67777-211-01PETROLATUM5 g in 1 PACKETJELLY514
67777-211-02PETROLATUM425.2 g in 1 JARJELLY425.214
67777-211-03PETROLATUM1 in 1 BOXJELLY114
67777-211-03PETROLATUM28.35 g in 1 TUBEJELLY28.3514
67777-211-07PETROLATUM113.4 g in 1 TUBEJELLY113.414
67777-211-07PETROLATUM6 in 1 BOXJELLY614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-211PETROLATUM JELLY [DYNAREX CORPORATION]14Legacy NDC, 7 package rows20130410_7edfdec2-0d03-4226-b173-23a56f7d353c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-211-01GM - Gram67777-211b3482979-9cc4-4a46-b08e-49de8d3d095212013-10-17
67777-211-02GM - Gram67777-2119981e6b6-a8a7-4a7b-8b0e-e0f8c51afe6512019-10-07
67777-211-03GM - Gram67777-21137953d1d-a444-40ce-b02a-722f968a18da12019-10-07
67777-211-07GM - Gram67777-211f0a8bfd5-b5a3-4412-9e2a-48054744ee4112017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U14
PETROLATUMACTIVE MOIETY4T6H12BN9U14

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
67777-21167777-211-01, 67777-211-02, 67777-211-03, 67777-211-07

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
98f2d4bc-3a59-45d5-91c1-11833a06dc897edfdec2-0d03-4226-b173-23a56f7d353c2013-04-09WarningsExact identifier
spl id: 98f2d4bc-3a59-45d5-91c1-11833a06dc89
spl set id: 7edfdec2-0d03-4226-b173-23a56f7d353c

Reported adverse events (FAERS/openFDA)#

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