FDA.reportPublic FDA data

Baby Petroleum Jelly

Manufacturer
Rejoice International Inc. | Jell Pharmaceuticals Pvt Ltd. | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:52

Label at a glance#

ProductBaby Petroleum Jelly
Active ingredientPETROLATUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                      Purpose

White Petroleum 99.9% ...... skin protectant

OTC - PURPOSE SECTION

Uses

temporarily protects and helps relieve chapped or cracked skin and lips

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

XtraCare

100% Pure Petroleum Jelly

Baby Fresh Scent

DOSAGE & ADMINISTRATION SECTION

Directions

  • change and cleanse diaper area, and allow to dry
  • apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged

WARNINGS SECTION

Warnings

For external use only

When using this product do not get into eyes

See a doctor if condition lasts more than 7 days

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

INACTIVE INGREDIENT SECTION

Inactive ingredients fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-076-01Baby Petroleum Jelly113 g in 1 PACKAGECREAM1137
57337-076-02Baby Petroleum Jelly170 g in 1 PACKAGECREAM1707
57337-076-03Baby Petroleum Jelly227 g in 1 PACKAGECREAM2277
57337-076-04Baby Petroleum Jelly368 g in 1 PACKAGECREAM3687

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-076BABY PETROLEUM JELLY (WHITE PETROLATUM) CREAM [REJOICE INTERNATIONAL INC.]7Current NDC, Legacy NDC, 4 package rows20241222_caf568aa-3889-41ff-835e-875bb6d9ca79.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-07657337-076-01, 57337-076-02, 57337-076-03, 57337-076-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
Baby Petroleum JellyWHITE PETROLATUMRejoice International Inc.caf568aa-3889-41ff-835e-875bb6d9ca792024-12-19WarningsExact identifier
ndc (package): 57337-076-04
ndc (package): 57337-076-02
ndc (package): 57337-076-01
ndc (package): 57337-076-03
ndc (product): 57337-076
ndc11 (package): 57337007601
ndc11 (package): 57337007602
ndc11 (package): 57337007603
ndc11 (package): 57337007604
spl id: 29a0bb73-acd5-32fc-e063-6394a90ab519
spl set id: caf568aa-3889-41ff-835e-875bb6d9ca79

Reported adverse events (FAERS/openFDA)#

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