FDA.reportPublic FDA data

DERMATITIS FACE BALM

Manufacturer
Canadian Custom Packaging Company
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:42:28

Label at a glance#

ProductDERMATITIS FACE BALM
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

Dosage and administration

Apply to affected areas as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.

Warnings

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected areas as needed.

OTHER INFORMATION

OTHER SAFETY INFORMATION

STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Beeswax, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Skinfix_.48oz_US_Face_Balm_D16983A_V9_R - box.jpgSkinfix_.48oz_US_Face_Balm_D16983A_V9_R - box.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1738987colloidal oatmeal 5 % Topical OintmentPSN3
1738987colloidal oatmeal 0.05 MG/MG Topical OintmentSCD3
1738987colloidal oatmeal 5 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54291-040-012026-01-29C16284748780-149896155-cb63-586f-e063-e6dba90add90Dermatitis Face Balm
54291-040-022026-01-29C16284748780-149896155-cb63-586f-e063-e6dba90add90Dermatitis Face Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54291-040-01DERMATITIS FACE BALM60 g in 1 TUBEOINTMENT603
54291-040-02DERMATITIS FACE BALM13.5 g in 1 TUBEOINTMENT13.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54291-040DERMATITIS FACE BALM (COLLOIDAL OATMEAL) OINTMENT [CANADIAN CUSTOM PACKAGING COMPANY]32 package rows20241213_80b5f707-a83b-7729-e053-2991aa0a1c56.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54291-04054291-040-01, 54291-040-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
SOYBEAN OIL241ATL177AIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
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
2902f16b-3a12-4687-e063-6394a90a8a1b80b5f707-a83b-7729-e053-2991aa0a1c562024-12-11WarningsExact identifier
spl id: 2902f16b-3a12-4687-e063-6394a90a8a1b
spl set id: 80b5f707-a83b-7729-e053-2991aa0a1c56

Reported adverse events (FAERS/openFDA)#

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