FDA.reportPublic FDA data

DUKAL WHITE PETROLATUM

Manufacturer
Dukal LLC
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:45

Label at a glance#

ProductDUKAL WHITE PETROLATUM
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor * cuts * scrapes * burns Temporarily helps protect and relieve chapped and cracked skin or lips Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged.

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#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum (USP, 100% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and relieve chapped and cracked skin or lips
  • Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bedtime 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 into 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 again in a few days.

Do not use on

OTC - DO NOT USE SECTION

  • deep 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 59-86°F (15-30°C)
  • Avoid excessive heat
  • Do not use is package is damaged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist NDC 65517-2023-1

WHITE PETROLATUM

SKIN PROTECTANT

5gm (.18oz)

ItemItemInnerInner

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

WHITE PETROLATUM

SKIN PROTECTANT

NDC 65517-2023-2

Dukal 1oz (28g)

PJ4325PJ4325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN5
204754petrolatum 1 MG/MG Topical OintmentSCD5
204754petrolatum 100 % Topical JellySY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2023-1DUKAL WHITE PETROLATUM6 in 1 CASEJELLY65
65517-2023-1DUKAL WHITE PETROLATUM144 in 1 BOXJELLY1445
65517-2023-2DUKAL WHITE PETROLATUM144 in 1 CASEJELLY1445
65517-2023-2DUKAL WHITE PETROLATUM28 g in 1 TUBEJELLY285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2023DUKAL WHITE PETROLATUM (PETROLATUM) JELLY [DUKAL LLC]5Current NDC, 4 package rows20241208_0c6474ed-2343-d5f2-e063-6394a90a30b3.zip

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
65517-202365517-2023-1, 65517-2023-2

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
DUKAL WHITE PETROLATUMPETROLATUMDukal LLC0c6474ed-2343-d5f2-e063-6394a90a30b32024-11-12WarningsExact identifier
ndc (package): 65517-2023-2
ndc (package): 65517-2023-1
ndc (product): 65517-2023
ndc11 (package): 65517202301
ndc11 (package): 65517202302
spl id: 26bc7f03-950e-5fc7-e063-6394a90a3e4d
spl set id: 0c6474ed-2343-d5f2-e063-6394a90a30b3

Reported adverse events (FAERS/openFDA)#

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