FDA.reportPublic FDA data

ASTONEA PETROLATUM

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-04-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:11:28

Label at a glance#

ProductASTONEA PETROLATUM
Active ingredientPETROLATUM
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor cuts, scrapes and burns Temporarily helps protect and helps relieve chapped and cracked skin or lips Helps prevent and protect from the drying effects of wind and cold weather Helps prevent and protect from chafed skin or mionr skin irritations associated with diaper rash, with each diaper change, especially at bedtime when expos...

Dosage and administration

Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply as needed

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum, USP, 100% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes and burns
  • Temporarily helps protect and helps relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect from chafed skin or mionr skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Warnings

WARNINGS SECTION

For External Use Only.

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • The condition persists or gets worse
  • Symptoms persists for more than 7 days or clear up and occur again within a few days.

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.

Other information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
  • Avoid excessive heat and humidity
  • Tamper evident
  • Do not use if packet is torn, cut or opened

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN5
204754petrolatum 1 MG/MG Topical OintmentSCD5
204754petrolatum 100 % Topical JellySY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-211-012026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-022026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-032026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-042026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-052026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-062026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-072026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM
77338-211-082026-01-29C16284748780-149896155-abb0-586f-e063-e6dba90add90ASTONEA PETROLATUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-211-01ASTONEA PETROLATUM5 g in 1 PACKETOINTMENT55
77338-211-02ASTONEA PETROLATUM56.6 g in 1 TUBEOINTMENT56.65
77338-211-03ASTONEA PETROLATUM368.5 g in 1 JAROINTMENT368.55
77338-211-04ASTONEA PETROLATUM226 g in 1 JAROINTMENT2265
77338-211-05ASTONEA PETROLATUM368 g in 1 JAROINTMENT3685
77338-211-06ASTONEA PETROLATUM425 g in 1 JAROINTMENT4255
77338-211-07ASTONEA PETROLATUM113 g in 1 TUBEOINTMENT1135
77338-211-08ASTONEA PETROLATUM100 g in 1 JAROINTMENT1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-211ASTONEA PETROLATUM (PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED]5Legacy NDC, 8 package rows20240426_e68adb93-047f-b5b6-e053-2995a90a59b9.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-21177338-211-01, 77338-211-02, 77338-211-03, 77338-211-04, 77338-211-05, 77338-211-06, 77338-211-07, 77338-211-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
16db3c14-4581-7608-e063-6294a90a3839e68adb93-047f-b5b6-e053-2995a90a59b92024-04-24WarningsExact identifier
spl id: 16db3c14-4581-7608-e063-6294a90a3839
spl set id: e68adb93-047f-b5b6-e053-2995a90a59b9

Reported adverse events (FAERS/openFDA)#

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