FDA.reportPublic FDA data

TARGETED BODY BALM

Manufacturer
Skinfix, Inc. | Canadian Custom Packaging Company
Effective date
2022-12-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:38

Label at a glance#

ProductTARGETED BODY 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

15 g

Skinfix_05oz_US_Targeted_Body_Balm_15.jpgSkinfix_05oz_US_Targeted_Body_Balm_15.jpg

60g

Skinfix_2oz_US_Targeted_Body_Balm_60.jpgSkinfix_2oz_US_Targeted_Body_Balm_60.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1486142colloidal oatmeal 2 % Topical OintmentPSN6
1486142colloidal oatmeal 0.02 MG/MG Topical OintmentSCD6
1486142colloidal oatmeal 2 % Topical OintmentSY6
1486142colloidal oatmeal 2 % Topical StickSY6

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
61328-122-052025-01-30C16284748780-12cef2736-9755-d83d-e063-dadaa90ab31fSKINFIX - ECZEMA+ TARGETED BODY BALM (61328-122)
61328-122-112025-01-30C16284748780-12cef2736-9755-d83d-e063-dadaa90ab31fSKINFIX - ECZEMA+ TARGETED BODY BALM (61328-122)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-122-05TARGETED BODY BALM15 g in 1 PACKAGEOINTMENT156
61328-122-11TARGETED BODY BALM60 g in 1 TUBEOINTMENT606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61328-122TARGETED BODY BALM (OATMEAL) OINTMENT [SKINFIX, INC.]6Legacy NDC, 2 package rows20221225_ada23bf4-4c10-4cc3-93b4-78e43ea16d31.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
61328-12261328-122-11, 61328-122-05

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
ALLANTOIN344S277G0ZIACT
YELLOW WAX2ZA36H0S2VIACT
SHEANUT OILO88E196QRFIACT
SOYBEAN OIL241ATL177AIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZIACT
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
860fce63-4fc8-40d1-84a2-a4dbef451fd7ada23bf4-4c10-4cc3-93b4-78e43ea16d312022-12-24WarningsExact identifier
spl id: 860fce63-4fc8-40d1-84a2-a4dbef451fd7
spl set id: ada23bf4-4c10-4cc3-93b4-78e43ea16d31

Reported adverse events (FAERS/openFDA)#

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