FDA.reportPublic FDA data

WHITE PETROLATUM

Manufacturer
Sion Biotext Medical Ltd
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:46:57

Label at a glance#

ProductWHITE PETROLATUM
Active ingredientPETROLATUM
Label structure8 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHITE PETROLATUM (USP)

SKIN PROTECTANT

Made in Israel

LabelLabel

Label 1Label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN17
204754petrolatum 1 MG/MG Topical OintmentSCD17
204754petrolatum 100 % Topical JellySY17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-211-01WHITE PETROLATUM144 in 1 BOXJELLY14417
68786-211-01WHITE PETROLATUM6 in 1 CASEJELLY617
68786-211-02WHITE PETROLATUM72 in 1 CASEJELLY7217
68786-211-02WHITE PETROLATUM1 in 1 BOXJELLY117
68786-211-03WHITE PETROLATUM100 in 1 CASEJELLY10017
68786-211-03WHITE PETROLATUM28.35 g in 1 TUBEJELLY28.3517
68786-211-04WHITE PETROLATUM72 in 1 CASEJELLY7217
68786-211-04WHITE PETROLATUM1 in 1 BOXJELLY117
68786-211-05WHITE PETROLATUM1 in 1 BOXJELLY117
68786-211-05WHITE PETROLATUM72 in 1 CASEJELLY7217
68786-211-06WHITE PETROLATUM92 g in 1 TUBEJELLY9217
68786-211-06WHITE PETROLATUM100 in 1 CASEJELLY10017
68786-211-07WHITE PETROLATUM12 in 1 BOXJELLY1217
68786-211-07WHITE PETROLATUM6 in 1 CASEJELLY617
68786-211-08WHITE PETROLATUM113 g in 1 TUBEJELLY11317
68786-211-08WHITE PETROLATUM100 in 1 CASEJELLY10017
68786-211-09WHITE PETROLATUM12 in 1 CASEJELLY1217
68786-211-09WHITE PETROLATUM425 g in 1 JARJELLY42517
68786-211-10WHITE PETROLATUM284 g in 1 TUBEJELLY28417
68786-211-10WHITE PETROLATUM24 in 1 CASEJELLY2417
68786-211-11WHITE PETROLATUM144 in 1 CASEJELLY14417
68786-211-11WHITE PETROLATUM28 g in 1 TUBEJELLY2817

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68786-211-01GM - Gram68786-211c6752c4b-4bfc-4e35-b89c-3735dd9285d312023-04-07

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 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68786-21168786-211-01, 68786-211-02, 68786-211-03, 68786-211-04, 68786-211-05, 68786-211-06, 68786-211-07, 68786-211-08, 68786-211-09, 68786-211-10, 68786-211-11

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162025-12-18monthly-update2026-06-03 17:46:22

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
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsExact identifier
ndc (package): 68786-211-03
ndc (package): 68786-211-10
ndc (package): 68786-211-01
ndc (package): 68786-211-02
ndc (package): 68786-211-04
ndc (package): 68786-211-08
ndc (package): 68786-211-11
ndc (package): 68786-211-09
ndc (package): 68786-211-05
ndc (package): 68786-211-06
ndc (package): 68786-211-07
ndc (product): 68786-211
ndc11 (package): 68786021107
ndc11 (package): 68786021109
ndc11 (package): 68786021102
ndc11 (package): 68786021105
ndc11 (package): 68786021101
ndc11 (package): 68786021108
ndc11 (package): 68786021103
ndc11 (package): 68786021110
ndc11 (package): 68786021104
ndc11 (package): 68786021106
ndc11 (package): 68786021111
spl id: 4b822859-4163-d637-e063-6294a90af8f8
spl set id: 53ca3aeb-1d5d-4964-adb5-1cfa901642da

Reported adverse events (FAERS/openFDA)#

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