FDA.reportPublic FDA data

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 00:14:17

Label at a glance#

ProductAstonea PeriShield
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

■ Helps treat and prevent rash associated with 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 and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 3.8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ Helps treat and prevent rash associated with 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 doesn't 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 and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water

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
1089065zinc oxide 3.8 % Topical OintmentPSN2
1089065zinc oxide 0.038 MG/MG Topical OintmentSCD2
1089065ZNO 0.038 MG/MG Topical OintmentSY2

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
77338-802-002024-06-25C16284748780-11030e365-2564-111a-e063-dadaa90a10e2astonea PeriShield
77338-802-042024-06-25C16284748780-11030e365-2564-111a-e063-dadaa90a10e2astonea PeriShield
77338-802-002024-01-30C16284748780-11030e365-2564-111a-e063-dadaa90a10e2astonea PeriShield
77338-802-042024-01-30C16284748780-11030e365-2564-111a-e063-dadaa90a10e2astonea PeriShield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-802-00AstoneaPeriShield100 g in 1 TUBEOINTMENT1002
77338-802-04AstoneaPeriShield452 g in 1 JAROINTMENT4522

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-802ASTONEA PERISHIELD (ZINC OXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 2 package rows20240627_e5d284f3-839e-cd25-e053-2995a90ad479.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-80277338-802-04, 77338-802-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALOE VERA LEAFZY81Z83H0XIACT
CHLOROXYLENOL0F32U78V2QIACT
CHOLECALCIFEROL1C6V77QF41IACT
CORN OIL8470G57WFMIACT
LANOLIN7EV65EAW6HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM BORATE91MBZ8H3QOIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ZINC OXIDESOI2LOH54ZACTIB

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
1bbb51fd-8753-894d-e063-6294a90a2c6be5d284f3-839e-cd25-e053-2995a90ad4792024-06-25WarningsExact identifier
spl id: 1bbb51fd-8753-894d-e063-6294a90a2c6b
spl set id: e5d284f3-839e-cd25-e053-2995a90ad479

Reported adverse events (FAERS/openFDA)#

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