FDA.reportPublic FDA data

HEALING ECZEMA BALM

Manufacturer
PROVINCE APOTHECARY INC
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:24

Label at a glance#

ProductHEALING ECZEMA BALM
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

Dosage and administration

Apply to affected areas of skin as needed Massage into extremely dry, cracked and chafed skin as often as needed for instant relief and long-lasting hydration. Apply generously.

Label contents#

Full prescribing information#

HEALING ECZEMA BALM

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Colloidal Oatmeal 1 %

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve minor skin irritation and itching due to:
    • eczema
    • rashes

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 persist for 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 product is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected areas of skin as needed
  • Massage into extremely dry, cracked and chafed skin as often as needed for instant relief and long-lasting hydration. Apply generously.

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Olea Europaea (Olive) Oil, Zinc Oxide, Cera Alba (Beesawax), Calendula Officinalis Flower Oil, Borago Officinalis (Borage) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Symphytum Officinale (Comfrey) Root Extract, Brassica Oleracea Italica (Broccoli) Seed Oul, Rosa Canina (Rosehip) Fruit Oil, Tocopherol (Vitamin E), Hypericum Perforatum (St.John's Wort) Oil, Propolis Cera, Curcuma Longa (Turmeric) Root Oil.

HEALING ECZEMA BALM 15g (72257-001-15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB_15HEB_15

ECZEMA BALM 80g (72257-001-80)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB_80gHEB_80g

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DrugFacts1DrugFacts1

DrugFacts2DrugFacts2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN4
240651colloidal oatmeal 10 MG/ML Topical CreamSCD4
240651Avena sativa 1 % Topical CreamSY4
240651colloidal oatmeal 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72257-001-152024-01-30C16284748780-1ba0f9c33-1e44-a910-e053-dadaa90a0b85HEALING ECZEMA BALM 15G 80G
72257-001-802024-01-30C16284748780-1ba0f9c33-1e44-a910-e053-dadaa90a0b85HEALING ECZEMA BALM 15G 80G
72257-001-152022-01-22C16284748780-1ba0f9c33-1e44-a910-e053-dadaa90a0b85HEALING ECZEMA BALM 15G 80G
72257-001-802022-01-22C16284748780-1ba0f9c33-1e44-a910-e053-dadaa90a0b85HEALING ECZEMA BALM 15G 80G
72257-001-152021-01-29C16284748780-1ba0f9c33-1e44-a910-e053-dadaa90a0b85HEALING ECZEMA BALM 15G 80G
72257-001-802021-01-29C16284748780-1ba0f9c33-1e44-a910-e053-dadaa90a0b85HEALING ECZEMA BALM 15G 80G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72257-001-15HEALING ECZEMA BALM1 in 1 BOXCREAM14
72257-001-15HEALING ECZEMA BALM15 g in 1 JARCREAM154
72257-001-80HEALING ECZEMA BALM80 g in 1 JARCREAM804
72257-001-80HEALING ECZEMA BALM1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72257-001HEALING ECZEMA BALM (OATMEAL) CREAM [PROVINCE APOTHECARY INC]4Legacy NDC, 4 package rows20220123_4a6ab3ce-14e4-419b-9f76-84deac708266.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72257-00172257-001-15, 72257-001-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
ZINC OXIDESOI2LOH54ZIACT
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
BORAGO OFFICINALIS SEED2GXJ790US0IACT
SUNFLOWER OIL3W1JG795YIIACT
COMFREY ROOTM9VVZ08EKQIACT
BROCCOLI SEED OILSY01LVD4G4IACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
PROPOLIS WAX6Y8XYV2NOFIACT
TURMERIC OIL6KGS8SP16UIACT
OATMEAL8PI54V663YACTIB

Source Document#

Source XML · Source PDF

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
d62cc9cc-e93f-0ed5-e053-2995a90ace984a6ab3ce-14e4-419b-9f76-84deac7082662022-01-01WarningsExact identifier
spl id: d62cc9cc-e93f-0ed5-e053-2995a90ace98
spl set id: 4a6ab3ce-14e4-419b-9f76-84deac708266

Reported adverse events (FAERS/openFDA)#

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