FDA.reportPublic FDA data

Promiseb Topical Cream

Primary DI
00368040753141
Brand
Promiseb Topical Cream
Company
Primus Pharmaceuticals, Inc.
Model
30 gm
Catalog number
75314
Device description
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.
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
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050158000SINCLAIR SEBORRHEA EMULSIONSinclair Pharmaceuticals, Ltd.2006-10-11FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00368040753141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00368040753141003680407531413680407531410368040753141

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
Weight30Gram

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
00368040752403EpiCeram® Skin Barrier Emulsion225 gm752402026-05-01

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Primary DI, Brand, Company table
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