PRIMUS PHARMACEUTICALS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30060528753006052875PRIMUS PHARMACEUTICALS, INC.1N2026-01-017373 N SCOTTSDALE RD STE B200 Scottsdale AZ US 85253

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2180811153709372K052643EPICERAMFRO2006-04-11
2180812023404208K050158SINCLAIR SEBORRHEA EMULSIONFRO2006-10-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO22006-10-11

NDC#

Impoyz

Primus Pharmaceuticals, Inc.

clobetasol propionate

Sernivo

Primus Pharmaceuticals, Inc.

betamethasone dipropionate

GUDID#

EpiCeram® Skin Barrier Emulsion - 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.

Primus Pharmaceuticals, Inc.

2026-05-01

EpiCeram® Skin Barrier Emulsion - 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.

Primus Pharmaceuticals, Inc.

2026-05-01

Promiseb Topical Cream - Promiseb Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. Under the supervision of a healthcare professional, Promiseb Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Promiseb Topical Cream helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Primus Pharmaceuticals, Inc.

2026-05-01