FDA.reportPublic FDA data

Petroleum Jelly Cocoa Butter Scent 3.53oz

Manufacturer
Rejoice International Corp. | Gandhar Oil Refinery (India) Ltd. | UMENDRA LIFE SCIENCES PRIVATE LIMITED | Astonea Labs Private Limited | VASA Cosmetics Private Limited
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:43:15

Label at a glance#

ProductPetroleum Jelly Cocoa Butter Scent 3.53oz
Active ingredientPETROLATUM
Label structure7 sections

Dosage and administration

apply as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 99.6%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Use

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symtoms last more than 7 days or clear up and occur again within a few days.

Do not use

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 ingredient

INACTIVE INGREDIENT SECTION

Fragrance

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1252009petrolatum 99.6 % Topical GelPSN5
1252009petrolatum 0.996 MG/MG Topical GelSCD5
1252009white petrolatum 99.6 % Topical GelSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130849607072917GTIN-13: 0849607072917
EAN-13: 0849607072917
GTIN-12: 849607072917
UPC-A: 849607072917
GTIN storage (14 digits): 00849607072917		57337-163.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-163-01Petroleum Jelly Cocoa Butter Scent 3.53oz100 g in 1 JAROINTMENT1005

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-16357337-163-01

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
PETROLATUM4T6H12BN9UACTIB
FRAGRANCE 135765EM498GW35IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-07-03full-release2026-06-01 01:06:27

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
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
ndc (package): 57337-163-01
ndc (product): 57337-163
ndc11 (package): 57337016301
spl id: 43569a51-308a-cb26-e063-6394a90a8a0d
spl set id: 1309b15b-5236-6e9f-e063-6294a90afe11

Reported adverse events (FAERS/openFDA)#

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