FDA.reportPublic FDA data

Petroleum Jelly

Manufacturer
Jell Pharmaceuticals Pvt. Ltd. | Jell Pharmaceuticals Pvt Ltd.
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-10 01:03:18

Label at a glance#

ProductPure Petrolatum Jelly
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

temporarily protects minor cuts, scrapes, burns and sunburn temporarily protects and helps relieve chapped or cracked skin helps protect from the drying effects of wind and cold weather helps treat and prevent diaper rash helps seal out wetness

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum (100% w/w)

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor cuts, scrapes, burns and sunburn
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • helps treat and prevent diaper rash
  • helps seal out wetness

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 for more than 7 days or clean up and occur again in 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 Ingredient

INACTIVE INGREDIENT SECTION

none

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
30400-50930400-509-01, 30400-509-02, 30400-509-03, 30400-509-04, 30400-509-05

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
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-09-02daily-update2026-09-04 01:01:31
22024-12-18full-release2026-06-01 00:44:59

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
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
ndc (package): 30400-509-02
ndc (package): 30400-509-03
ndc (package): 30400-509-01
ndc (product): 30400-509
ndc11 (package): 30400050903
ndc11 (package): 30400050902
ndc11 (package): 30400050901
spl set id: cdc297cb-476a-6da9-e053-2a95a90a399a

Reported adverse events (FAERS/openFDA)#

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