FDA.reportPublic FDA data

ASTONEA A&D Ointment WITH LANOLIN

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:25

Label at a glance#

ProductASTONEA A and D WITH LANOLIN
Active ingredientLANOLIN, PETROLATUM
Label structure8 sections

Indications and uses

helps treat and prevent diaper rash temporarily protects minor: cuts scrapes burns temporarily protects and helps relieve chapped, chafed or cracked skin and lips protect chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

for skin protectant use apply as needed for diaper rash use: change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage and handling

store between 20°C to 25 °C ( 68° to 77°F) do not use if tube seal under cap is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lanolin 15.5%Skin Protectant
Petrolatum 53.4%Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
  • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
  • protect chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds .
  • animal bites
  • serious burns .

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 within a few days

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protectant useapply as needed
  • for diaper rash use:
    • change wet and soiled diapers promptly
    • cleanse the diaper area, and allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

STORAGE AND HANDLING SECTION

  • store between 20°C to 25 °C ( 68° to 77°F)
  • do not use if tube seal under cap is broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cholecalciferol, light mineral oil, microcrystalline wax, paraffin, vitamin A palmitate

TheraCare A&D Ointment

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
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN1
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY1
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY1

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-213-04ASTONEA A and D WITH LANOLIN1 in 1 CARTONOINTMENT11
77338-213-04ASTONEA A and D WITH LANOLIN113 g in 1 TUBEOINTMENT1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-213ASTONEA A AND D WITH LANOLIN (LANOLIN, PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED]12 package rows20240307_12eff01f-9f1e-0ce3-e063-6294a90a0faa.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
77338-21377338-213-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
LIGHT MINERAL OILN6K5787QVPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PARAFFINI9O0E3H2ZEIACT
LANOLIN7EV65EAW6HACTIB
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
12f000b0-3ae7-bcd7-e063-6394a90aee5812eff01f-9f1e-0ce3-e063-6294a90a0faa2024-03-05WarningsExact identifier
spl id: 12f000b0-3ae7-bcd7-e063-6394a90aee58
spl set id: 12eff01f-9f1e-0ce3-e063-6294a90a0faa

Reported adverse events (FAERS/openFDA)#

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