FDA.reportPublic FDA data

Pure Petrolatum Jelly

Manufacturer
UMENDRA LIFE SCIENCES PRIVATE LIMITED
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:25

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

Drug FactDrug Fact

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN1
204754petrolatum 1 MG/MG Topical OintmentSCD1
204754petrolatum 100 % Topical JellySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85114-1010-1Pure Petrolatum Jelly226 g in 1 JARJELLY2261
85114-1010-3Pure Petrolatum Jelly368 g in 1 JARJELLY3681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85114-1010PURE PETROLATUM JELLY (PETROLATUM) JELLY [UMENDRA LIFE SCIENCES PRIVATE LIMITED]12 package rows20250403_31be21c3-984b-de50-e063-6394a90a86ff.zip

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
85114-101085114-1010-3, 85114-1010-1

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
57fed1bf-32c2-46ee-e063-6294a90a2f7531be21c3-984b-de50-e063-6394a90a86ff2026-08-01WarningsExact identifier
spl set id: 31be21c3-984b-de50-e063-6394a90a86ff

Reported adverse events (FAERS/openFDA)#

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