FDA.reportPublic FDA data

IASOBETIC Allantoin Skin Protectant Cream

Manufacturer
IASOBETIC WOUND CARE CORP.
Effective date
2020-02-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:52

Label at a glance#

ProductIASOBETIC Allantoin Skin Protectant
Active ingredientALLANTOIN
Label structure7 sections

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

  • temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • helps prevent and temporarily protects chafed, chapped or cracked skin

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 within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 15-27° C (59-80° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera leaf juice, shea butter, turmeric, coconut oil, carbomer, cetyl alcohol, dimethicone, diatomite, glucosamine, glycol stearate SE, EDTA disodium, ethylhexylglycerin, glycerin, isopropyl myristate, laureth-8, lecithin, gotu kola, stearic acid, plantain leaf extract powder, phenoxyethanol, hydrogenated polydecene, purified water, pullulan, sodium acrylate/sodium acryloyldimethyl taurate copolymer, sclerotium gum, triethanolamine, xanthan gum.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72904-001-502022-01-28C16284748780-1d6a99b39-6d1f-a426-e053-dadaa90af4c2IASOBETIC Allantoin Skin Protectant Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72904-001-50IASOBETIC Allantoin Skin Protectant1 in 1 BOXCREAM12
72904-001-50IASOBETIC Allantoin Skin Protectant50 g in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72904-001IASOBETIC ALLANTOIN SKIN PROTECTANT (ALLANTOIN) CREAM [IASOBETIC WOUND CARE CORP.]2Legacy NDC, 2 package rows20200301_5b2cf65a-e6ba-4d0b-857e-03f1eecaec72.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72904-00172904-001-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
TURMERIC856YO1Z64FIACT
COCONUT OILQ9L0O73W7LIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
GLUCOSAMINEN08U5BOQ1KIACT
GLYCOL STEARATE SE6YLY96TQL6IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-8QU7U88D04IIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
PULLULAN8ZQ0AYU1TTIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
BETASIZOFIRAN2X51AD1X3TIACT
TROLAMINE9O3K93S3TKIACT
XANTHAN GUMTTV12P4NEEIACT
ALLANTOIN344S277G0ZACTIB

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
9e8c6d1c-ba65-6a7c-e053-2995a90a517d5b2cf65a-e6ba-4d0b-857e-03f1eecaec722020-02-14WarningsExact identifier
spl id: 9e8c6d1c-ba65-6a7c-e053-2995a90a517d
spl set id: 5b2cf65a-e6ba-4d0b-857e-03f1eecaec72

Reported adverse events (FAERS/openFDA)#

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