FDA.reportPublic FDA data

EpiCeram® Skin Barrier Emulsion

Primary DI
00368040752175
Brand
EpiCeram® Skin Barrier Emulsion
Company
Primus Pharmaceuticals, Inc.
Model
90 gm
Catalog number
75217
Device description
EpiCeram® Skin Barrier Emulsion is a steroid free, fragrance free, ceramide dominant emulsion containing ceramide, conjugated linoleic acid (CLA), and cholesterol in a 3:1:1 ratio, respectively, in an emollient base. These lipids mimic those commonly found in skin. EpiCeram is used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, contact dermatitis (allergic and/or irritant), and radiation dermatitis. EpiCeram helps to relieve dry, waxy skin by maintaining a moist environment which aids the healing process.
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052643000EPICERAMCeragenix Corporation2006-04-11FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00368040752175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00368040752175003680407521753680407521750368040752175

GMDN Terms#

Term, Definition table
TermDefinition
Skin semi-occlusive dressing, non-antimicrobialA substance (e.g., gel, ointment) intended to be topically applied to injured/diseased skin to expedite healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the skin to the environment by means of a physical barrier; it may also prevent abnormal scar formation and does not include an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds and/or conditions such as lacerations, burns, surgical wounds, radiation dermatitis, and inflammation. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight90Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
130834745
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00368040752403EpiCeram® Skin Barrier Emulsion225 gm752402026-05-01
00368040753141Promiseb Topical Cream30 gm753142026-05-01

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Primary DI, Brand, Company table
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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
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