Device
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,...
Manufacturer
Primus Pharmaceuticals, Inc.
Primus Pharmaceuticals, Inc.
Model: 90 gm
Catalog: 75217
DI: 00368040752175
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e0c6be6b-b6ac-4b30-b41b-ac76978c5c8b
Distribution Status:
In Commercial Distribution
DUNS Number:
130834745
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00368040752175
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62069
Name: Skin semi-occlusive dressing, non-antimicrobial
Definition:
A 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.
FDA Product Codes
FRO
Dressing, Wound, Drug
Premarket Submissions
Submission Number:
K052643
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gram
Device Size - Size - @attributes - Value:
90
Device Size - Size Type:
Weight
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature