FDA.reportPublic FDA data

Arctiva Eczema Cream

Manufacturer
Epic Laboratories, LLC
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:41:47

Label at a glance#

ProductArctiva Eczema Cream
Active ingredientOATMEAL
Label structure11 sections

Storage and handling

Other Information: Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Colloidal oatmeal 1%......

OTC - PURPOSE SECTION

Purpose... Skin protectant

INDICATIONS & USAGE SECTION

Uses: Temporarily protects and helps relieve minor skin irritations, redness, dryness, cracking and itching

due to eczema and dermatitis.

WARNINGS SECTION

Warnings

For external use only. When using this product: do not get into eyes.

Stop using and ask a doctor if: condition worsen, 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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions Apply twice daily or as needed.
For best results apply after cleansing.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Cetyl Alcohol, Stearyl Alcohol,

Candelila/Jojoba/Rice Bran Polyglyceryl-3 esters, Glyceryl Stearate,
Sodium Hydroxide, Sodium stearoyl lactylate,Cetearyl Alcohol, Phenoxyethanol, Pentylene Glycol,

Hydrosuf (Glycolipids), Glycolic Acid, Vitamin B3 (Niacinamide), Hydroxyethylcellulose, Ethylhexyglycerin,

Sodium Ascorbyl Phosphate, Vitamin A (Retinyl Palmitate), Tocopherol, Soybean Oil.

STORAGE AND HANDLING SECTION

Other Information: Store at room temperature.

OTC - QUESTIONS SECTION

Questions: 1-833-933-SKIN (7546)

SPL UNCLASSIFIED SECTION

THE ARCTIVA GUARANTEE

Arctiva relief goes beyond the surface. If for any reason you're

not completely satisfied contact us within 60 days of your purchase

for a full refund.

Distributed by:

Arctiva Wellness, LLC

30600 Aurora Rd.

Suite 180

Salon, OH 44139

Made in U.S.A

arctivaskin.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

eczema 130ml cartoneczema 130ml carton

eczema 130ml labeleczema 130ml label

eczema 40ml cartoneczema 40ml carton

eczema 40ml labeleczema 40ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-821-442025-01-28C16284748780-11030e365-6bdd-111a-e063-dadaa90a10e2Arctiva Eczema Cream
58418-821-992025-01-28C16284748780-11030e365-6bdd-111a-e063-dadaa90a10e2Arctiva Eczema Cream
58418-821-442024-07-30C16284748780-11030e365-6bdd-111a-e063-dadaa90a10e2Arctiva Eczema Cream
58418-821-992024-07-30C16284748780-11030e365-6bdd-111a-e063-dadaa90a10e2Arctiva Eczema Cream
58418-821-442024-01-30C16284748780-11030e365-6bdd-111a-e063-dadaa90a10e2Arctiva Eczema Cream
58418-821-992024-01-30C16284748780-11030e365-6bdd-111a-e063-dadaa90a10e2Arctiva Eczema Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-821ARCTIVA ECZEMA CREAM (ECZEMA CREAM) CREAM [EPIC LABORATORIES, LLC]5Unmatched20250130_eff67352-3adc-0efa-e053-2995a90a12b3.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-82158418-821-45, 58418-821-99, 58418-821-40, 58418-821-44

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
NIACINAMIDE25X51I8RD4IACT
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9EIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
RICE BRANR60QEP13ICIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
OATMEAL8PI54V663YACTIB
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCOLIC ACID0WT12SX38SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CANDELILLA WAXWL0328HX19IACT
LIPID A 504Q2VF73396UIACT

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
4c202e1d-4c6a-8f54-e063-6394a90a6fbaeff67352-3adc-0efa-e053-2995a90a12b32026-03-03WarningsExact identifier
spl set id: eff67352-3adc-0efa-e053-2995a90a12b3

Reported adverse events (FAERS/openFDA)#

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