FDA.reportPublic FDA data

Astonea Skin Protectant

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 00:14:17

Label at a glance#

ProductAstonea Skin Protectant
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash, incontinence or exposure to feces and urine Protects Skin against irritation due to such rash and Helps protect skin from exposure to wetness

Dosage and administration

Change wet or solied diapers promptly Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs Allow to dry Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (1.8% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects Skin against irritation due to such rash and
  • Helps protect skin from exposure to wetness

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • If eye contact occurs, flush with water

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens or does not improve within seven 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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Change wet or solied diapers promptly
  • Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
  • Allow to dry
  • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), Ethylhexylglycerine, FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, stearic acid, Vitamin A Palmitate, Water.

Package Labeling:

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
1044412zinc oxide 1.8 % Topical OintmentPSN3
1044412zinc oxide 0.018 MG/MG Topical OintmentSCD3
1044412zinc oxide 1.8 % Topical OintmentSY3
1044412ZNO 0.018 MG/MG Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - 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
77338-050-042024-06-25C16284748780-11030e365-1d76-111a-e063-dadaa90a10e2Astonea skin protectant 1.8% ZNO
77338-050-042024-01-30C16284748780-11030e365-1d76-111a-e063-dadaa90a10e2Astonea skin protectant 1.8% ZNO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-050-04Astonea Skin Protectant113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-050ASTONEA SKIN PROTECTANT (ZINC OXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]3Current NDC, Legacy NDC, 1 package rows20240627_e3c7a515-3e77-da85-e053-2995a90a3ee1.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-05077338-050-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAVENDER OILZBP1YXW0H8IACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
STEARIC ACID4ELV7Z65APIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHOLECALCIFEROL1C6V77QF41IACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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 Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
ndc (package): 77338-050-04
ndc (product): 77338-050
ndc11 (package): 77338005004
spl id: 1bbb3c29-f7ab-8b08-e063-6294a90a0129
spl set id: e3c7a515-3e77-da85-e053-2995a90a3ee1

Reported adverse events (FAERS/openFDA)#

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