Astonea

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:19

Label at a glance#

ProductAstonea Vitamin A and D
Active ingredientPETROLATUM
Label structure12 sections

Indications and uses

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

Dosage and administration

 for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petroleum Jelly USP (76% 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 ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash  ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

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 more than 7 days or clear up and occur again in a few days

Do not use on

OTC - DO NOT USE SECTION

■ animal bites ■ deep or puncture wounds ■ serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

 for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Other Information

SPL UNCLASSIFIED SECTION

■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cholecalciferol, Lanolin, Light Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A Palmitate

Package Label

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
1049072petrolatum 76 % Topical OintmentPSN2
1049072petrolatum 0.76 MG/MG Topical OintmentSCD2
1049072petrolatum 76 % Topical OintmentSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-307-02AstoneaVitamin A and D5 g in 1 PACKETOINTMENT52
77338-307-03AstoneaVitamin A and D28.3 g in 1 TUBEOINTMENT28.32
77338-307-04AstoneaVitamin A and D113 g in 1 TUBEOINTMENT1132
77338-307-05AstoneaVitamin A and D425 g in 1 JAROINTMENT4252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-307ASTONEA VITAMIN A AND D (WHITE PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Current NDC, Legacy NDC, 4 package rows20240627_ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-30777338-307-02, 77338-307-03, 77338-307-04, 77338-307-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
ndc (package): 77338-307-02
ndc (package): 77338-307-03
ndc (package): 77338-307-05
ndc (package): 77338-307-04
ndc (product): 77338-307
ndc11 (package): 77338030705
ndc11 (package): 77338030704
ndc11 (package): 77338030703
ndc11 (package): 77338030702
spl id: 1bbb6d64-77d3-86e2-e063-6294a90abdc4
spl set id: ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf

Reported adverse events (FAERS/openFDA)#

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