FDA.reportPublic FDA data

Eczema Therapy

Manufacturer
Hamilton Therapeutics, Inc.
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:59

Label at a glance#

ProductEczema Therapy
Active ingredientOATMEAL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose
Colloidal Oatmeal 1% ..............................Skin Protectant

OTC - PURPOSE SECTION

Uses

Temporarily protects and helps relieve minor skin
irritation and itching due to: • Eczema • Rashes

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.

INDICATIONS & USAGE 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

WARNINGS SECTION

Warnings For external use only. When using this product • Avoid contact with eyes.

DOSAGE & ADMINISTRATION SECTION

Directions • Apply as needed to affected areas.
• Use on mild to moderate eczema, or as directed by a physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Butyrospermum Parkii (Shea) Butter, Bisabolol, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Honey, Sclerocarya Birrea Seed Oil, Glyceryl Stearate, Glycerin, Cetearyl Alcohol, Sorbitan Stearate, Sorbityl Laurate, Stearyl Alcohol, Potassium Cetyl Phosphate, Panthenol, Allantoin, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Niacinamide, Vegetable Oil, Sodium Hyaluronate, Xanthan Gum, Sodium PCA, Tetradecane, Arginine, Cetyl Phosphate, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eczema Therapy

8 FL OZ/ 236mL

Eczema thera tubeEczema thera tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3
240651Avena sativa 1 % Topical CreamSY3
240651colloidal oatmeal 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72381-103-012025-01-30C16284748780-1f386c649-d1e0-0266-e053-dadaa90a7c1aEczema Therapy
72381-103-012023-02-10C16284748780-1f386c649-d1e0-0266-e053-dadaa90a7c1aEczema Therapy
72381-103-012023-01-30C16284748780-1f386c649-d1e0-0266-e053-dadaa90a7c1aEczema Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72381-103-01Eczema Therapy236 mL in 1 TUBECREAM2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72381-103ECZEMA THERAPY (COLLOIDAL OATMEAL) CREAM [HAMILTON THERAPEUTICS, INC.]3Legacy NDC, 1 package rows20230212_6e61ba86-3359-c099-e053-2a91aa0a1484.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72381-10372381-103-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITYL LAURATE23XPH3M9LRIACT
CHAMOMILEFGL3685T2XIACT
ARGININE94ZLA3W45FIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
ALCOHOL3K9958V90MIACT
LEMON PEEL72O054U628IACT
SAGE065C5D077JIACT
NIACINAMIDE25X51I8RD4IACT
CETYL PHOSPHATEVT07D6X67OIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
TOCOPHEROLR0ZB2556P8IACT
SHEA BUTTERK49155WL9YIACT
CITRUS AURANTIUM FLOWERO730ZX2Z83IACT
CORN OIL8470G57WFMIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
TETRADECENEFW23481S7SIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
OATMEAL8PI54V663YACTIB
SUNFLOWER OIL3W1JG795YIIACT
HONEYY9H1V576FHIACT
XANTHAN GUMTTV12P4NEEIACT
ORANGE PEELTI9T76XD44IACT
THYMECW657OBU4NIACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT

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
f461455c-16d3-70b6-e053-2a95a90abb8e6e61ba86-3359-c099-e053-2a91aa0a14842023-02-10WarningsExact identifier
spl id: f461455c-16d3-70b6-e053-2a95a90abb8e
spl set id: 6e61ba86-3359-c099-e053-2a91aa0a1484