FDA.reportPublic FDA data

ASTONEA XERO

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:18

Label at a glance#

ProductASTONEA XERO
Active ingredientZINC OXIDE, DIMETHICONE
Label structure10 sections

Indications and uses

Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Dosage and administration

Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

​Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Dimethicone 1%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with

diaper rash and helps seal out wetness.

​Warnings:

WARNINGS SECTION

  • For external use only,
  • Avoid contact with eyes, In case of contact, flush thoroughly with water.

Warnings:

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor If

• condition worsens
• symptoms last more than 7 days or clear up and
occur again within a few days.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information:

OTHER SAFETY INFORMATION

  • Store between 15-30 °C

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe vera Extract, Cholecalciferol, Eugenia Caryophyllus Flower Oil, Lanolin, Light Liquid Paraffin, Petrolatum, Retinyl Palmitate,Tocopheryl Acetate

Label 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
2609848dimethicone 1 % / zinc oxide 15 % Topical OintmentPSN3
2609848dimethicone 0.01 MG/MG / zinc oxide 0.15 MG/MG Topical OintmentSCD3
2609848dimethicone 0.01 MG/MG / ZNO 0.15 MG/MG Topical OintmentSY3
2609848dimethicone 1 % / zinc oxide 15 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-022-232024-06-25C16284748780-11030e365-0c7f-111a-e063-dadaa90a10e2ASTONEA XERO
77338-022-232024-01-30C16284748780-11030e365-0c7f-111a-e063-dadaa90a10e2ASTONEA XERO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-022-23ASTONEA XERO113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-022ASTONEA XERO (SKIN PROTECTANT) OINTMENT [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 1 package rows20240627_e69ab651-9f37-8cb8-e053-2a95a90a88e3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-02277338-022-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
LIGHT MINERAL OILN6K5787QVPIACT
CHOLECALCIFEROL1C6V77QF41IACT
ALOE VERA LEAFZY81Z83H0XIACT
CLOVE LEAF OILVCA5491KVFIACT
LANOLIN7EV65EAW6HIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OACTIB

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
1bbb38e8-e919-5421-e063-6394a90a000ee69ab651-9f37-8cb8-e053-2a95a90a88e32024-06-25WarningsExact identifier
spl id: 1bbb38e8-e919-5421-e063-6394a90a000e
spl set id: e69ab651-9f37-8cb8-e053-2a95a90a88e3

Reported adverse events (FAERS/openFDA)#

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