FDA.reportPublic FDA data

Shea Butter Petroleum Jelly

Manufacturer
Jell Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:19

Label at a glance#

ProductShea Butter Petroleum Jelly
Active ingredientPETROLATUM
Label structure12 sections

Indications and uses

temporarily protects minor: cuts, scrapes, burns; temporarily protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (99.6%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INTENDED USE OF THE DEVICE

temporarily protects minor: cuts, scrapes, burns; temporarily protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

INDICATIONS & USAGE SECTION

do not get into eyes

Stop use and ask a doctor if

PRECAUTIONS SECTION

condition worsens, symptoms last longer than 7 days or clear up and occur again within 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

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

butyrospermum parkii (shea butter), fragrance

Questions or comments?

OTC - QUESTIONS SECTION

1-800-925-4733

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shea Butter Petroleum JellyShea Butter Petroleum Jelly

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1252009petrolatum 99.6 % Topical GelPSN2
1252009petrolatum 0.996 MG/MG Topical GelSCD2
1252009white petrolatum 99.6 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-501-01Shea Butter Petroleum Jelly368 g in 1 JARJELLY3682
30400-501-02Shea Butter Petroleum Jelly49 g in 1 JARJELLY492
30400-501-03Shea Butter Petroleum Jelly100 g in 1 JARJELLY1002
30400-501-04Shea Butter Petroleum Jelly113 g in 1 JARJELLY1132
30400-501-05Shea Butter Petroleum Jelly170 g in 1 JARJELLY1702
30400-501-06Shea Butter Petroleum Jelly425 g in 1 JARJELLY4252
30400-501-07Shea Butter Petroleum Jelly226 g in 1 JARJELLY2262
30400-501-08Shea Butter Petroleum Jelly283 g in 1 JARJELLY2832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-501SHEA BUTTER PETROLEUM JELLY (PETROLATUM JELLY) JELLY [JELL PHARMACEUTICALS PVT. LTD.]2Current NDC, Legacy NDC, 8 package rows20241219_cd848f33-e863-d3af-e053-2a95a90a45b1.zip

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
30400-50130400-501-01, 30400-501-02, 30400-501-03, 30400-501-04, 30400-501-05, 30400-501-06, 30400-501-07, 30400-501-08

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
SHEA BUTTERK49155WL9YIACT
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
Shea Butter Petroleum JellyPETROLATUM JELLYJell Pharmaceuticals Pvt. Ltd.cd848f33-e863-d3af-e053-2a95a90a45b12024-12-17WarningsExact identifier
ndc (package): 30400-501-07
ndc (package): 30400-501-06
ndc (package): 30400-501-08
ndc (package): 30400-501-01
ndc (package): 30400-501-04
ndc (package): 30400-501-03
ndc (package): 30400-501-05
ndc (package): 30400-501-02
ndc (product): 30400-501
ndc11 (package): 30400050105
ndc11 (package): 30400050103
ndc11 (package): 30400050107
ndc11 (package): 30400050108
ndc11 (package): 30400050104
ndc11 (package): 30400050101
ndc11 (package): 30400050106
ndc11 (package): 30400050102
spl id: 29768db2-7b93-f182-e063-6394a90a0ad3
spl set id: cd848f33-e863-d3af-e053-2a95a90a45b1

Reported adverse events (FAERS/openFDA)#

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