FDA.reportPublic FDA data

Eczema Balm

Manufacturer
Skinfix, Inc.
Effective date
2017-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:17:36

Label at a glance#

ProductEczema 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 as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

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.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with eyes
OTC - ASK DOCTOR SECTION

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 as needed.

Other Information

OTHER SAFETY INFORMATION

Store at 65-80°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 (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Zinc Oxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

US_EczemaBalm_Tube2oz_V11_OL_RUS_EczemaBalm_Tube2oz_V11_OL_R

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
61328-11561328-115-12, 61328-115-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
YELLOW WAX2ZA36H0S2VIACT
SHEANUT OILO88E196QRFIACT
SOYBEAN OIL241ATL177AIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZIACT

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
54532f8e-59a4-486a-b2a8-c9d5e2a6a4c6b9389d83-e62e-4ad5-97b6-ab9622c156f82017-03-15WarningsExact identifier
spl id: 54532f8e-59a4-486a-b2a8-c9d5e2a6a4c6
spl set id: b9389d83-e62e-4ad5-97b6-ab9622c156f8

Reported adverse events (FAERS/openFDA)#

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