FDA.reportPublic FDA data

HEALING ECZEMA BALM

Manufacturer
PROVINCE APOTHECARY INC
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:11:16

Label at a glance#

ProductHEALING ECZEMA BALM
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes poison ivy insect bites

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#

DRUG FACTS

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
  • poison ivy
  • insect bites

Warnings

WARNINGS SECTION

  • Do not use if tamper seal is broken
  • 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.

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

Borago Officinalis (Borage) Seed Oil*, Brassica Oleracea Italica (Broccoli) Seed Oil, Calendula Officinalis Flower Oil*, Cera Alba (Beesawax), Curcuma Longa (Turmeric) Root Oil*, Mangifera Indica (Mango) Seed Butter*, Olea Europaea (Olive) Fruit Oil*, Rosa Canina (Rosehip) Fruit Oil*, Tocopherol (Vitamin E), Zinc Oxide.

* Certified organic.

HEALING ECZEMA BALM 50g (72257-050-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Eczema Balm 50gHealing Eczema Balm 50g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72257-050-002024-01-30C16284748780-11030e365-1a72-111a-e063-dadaa90a10e2HEALING ECZEMA BALM 50G

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72257-050HEALING ECZEMA BALM (OATMEAL) CREAM [PROVINCE APOTHECARY INC]1Legacy NDC20220129_d696b34b-dbce-500a-e053-2a95a90a8603.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72257-05072257-050-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
OLIVE OIL6UYK2W1W1EIACT
ZINC OXIDESOI2LOH54ZIACT
YELLOW WAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
BORAGO OFFICINALIS SEED2GXJ790US0IACT
BROCCOLI SEED OILSY01LVD4G4IACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PROPOLIS WAX6Y8XYV2NOFIACT
TURMERIC OIL6KGS8SP16UIACT
OATMEAL8PI54V663YACTIB

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
d696bb27-785c-f915-e053-2995a90a624cd696b34b-dbce-500a-e053-2a95a90a86032022-01-01WarningsExact identifier
spl id: d696bb27-785c-f915-e053-2995a90a624c
spl set id: d696b34b-dbce-500a-e053-2a95a90a8603

Reported adverse events (FAERS/openFDA)#

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