M3 NATURALS Eczema Cream

Manufacturer
M3 Naturals LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:04

Label at a glance#

ProductM3 NATURALS Eczema Cream
Active ingredientOATMEAL
Label structure7 sections

Dosage and administration

Adults and children two-years of age or older: Apply as needed Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Indications:

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to ■ Eczema or ■ rashes.

Warnings:

WARNINGS SECTION

■ For external use only.  ■ Avoid contact with eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, consult physician.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older: Apply as needed
  • Children under two-years of age: consult a physician.

Additional Information:

SPL UNCLASSIFIED SECTION

for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Organic Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN2
240651colloidal oatmeal 10 MG/ML Topical CreamSCD2
240651Avena sativa 1 % Topical CreamSY2
240651colloidal oatmeal 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81985-186-012023-11-11C16284748780-1f386c64a-2ed2-0266-e053-dadaa90a7c1aM3 NATURALS: Eczema Cream
81985-186-012023-01-30C16284748780-1f386c64a-2ed2-0266-e053-dadaa90a7c1aM3 NATURALS: Eczema Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81985-186-01M3 NATURALS Eczema Cream118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81985-186M3 NATURALS ECZEMA CREAM (OATMEAL) CREAM [M3 NATURALS LLC]2Current NDC, Legacy NDC, 1 package rows20231112_45e2cdde-58fb-4eea-a54d-f53f9ad0d854.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81985-18681985-186-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
ndc (package): 81985-186-01
ndc (product): 81985-186
ndc11 (package): 81985018601
spl id: 09e2e2ce-d85c-0711-e063-6294a90a9213
spl set id: 45e2cdde-58fb-4eea-a54d-f53f9ad0d854

Reported adverse events (FAERS/openFDA)#

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