FDA.reportPublic FDA data

EpiCeram® Skin Barrier Emulsion

Primary DI
00368040752403
Brand
EpiCeram® Skin Barrier Emulsion
Company
Primus Pharmaceuticals, Inc.
Model
225 gm
Catalog number
75240
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
00368040752403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00368040752403003680407524033680407524030368040752403

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
Weight225Gram

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
00368040752175EpiCeram® Skin Barrier Emulsion 90 gm752172026-05-01
00368040753141Promiseb Topical Cream30 gm753142026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
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10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
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06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08