FDA.reportPublic FDA data

DERMOIA Manuka Honey Eczema Cream

Manufacturer
TREASUREWISE LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:04

Label at a glance#

ProductDERMOIA Manuka Honey Eczema Cream
Active ingredientOATMEAL
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve minor skin irritation and itching due to:
  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last 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, get medical help or contact a Poison Control Center right away.

If pregnant or beast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Arnica Montana Flower Extract, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Chamomilia Recutita (Chamomile) Extract, Citric Acid, dl-Panthenol, Ethylhexylglycerin, Euterpe Oleracea (Acai) Extract, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Isopropyl Myristate, Magnesium Aluminum Silicate, Manuka Honey, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Linum Usitatissimum (Flaxseed) Oil, Oryza Sativa (Rice) Bran Oil, Passiflora Incarnata (Passion Fruit) Extract, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83524-407-00DERMOIA Manuka Honey Eczema Cream120 mL in 1 JARCREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83524-407DERMOIA MANUKA HONEY ECZEMA CREAM (OATMEAL) CREAM [TREASUREWISE LLC]2Current NDC, 1 package rows20231106_a48e52a3-b681-4489-a1fd-6b09d8bc9c55.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83524-40783524-407-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CERAMIDE NGC04977SRJ5IACT
CERAMIDE NP4370DF050BIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACAI46AM2VJ0AWIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYALURONIC ACIDS270N0TRQYIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
TEA TREE OILVIF565UC2GIACT
NIACINAMIDE25X51I8RD4IACT
FLAX SEED4110YT348CIACT
RICE BRAN OILLZO6K1506AIACT
AVOCADO OIL6VNO72PFC1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
JOJOBA OIL724GKU717MIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
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
DERMOIA Manuka Honey Eczema CreamOATMEALTREASUREWISE LLCa48e52a3-b681-4489-a1fd-6b09d8bc9c552023-11-06WarningsExact identifier
ndc (package): 83524-407-00
ndc (product): 83524-407
ndc11 (package): 83524040700
spl id: 0976cebf-697b-e194-e063-6394a90a8fd9
spl set id: a48e52a3-b681-4489-a1fd-6b09d8bc9c55

Reported adverse events (FAERS/openFDA)#

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