DERMATITIS FACE BALM

Manufacturer
Skinfix, Inc. | Canadian Custom Packaging Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:10

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

Petrolatum, Glycine Soja (Soybean) Oil, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Paraffin, Allantoin, Tocopherol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61328-121-1261328-121-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1738987colloidal oatmeal 5 % Topical OintmentPSN7
1738987colloidal oatmeal 0.05 MG/MG Topical OintmentSCD7
1738987colloidal oatmeal 5 % Topical OintmentSY7

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-121-12DERMATITIS FACE BALM13.5 g in 1 TUBEOINTMENT13.57

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
61328-12161328-121-12

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-12-26full-release2026-06-01 00:49:08

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
DERMATITIS FACE BALMCOLLOIDAL OATMEALSkinfix, Inc.86d2db7d-f1d4-4bca-aba4-d4c96b83c1a62026-01-08WarningsExact identifier
ndc (package): 61328-121-12
ndc (product): 61328-121
ndc11 (package): 61328012112
spl id: 47ebdead-4009-888b-e063-6394a90a1362
spl set id: 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6

Reported adverse events (FAERS/openFDA)#

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