FDA.reportPublic FDA data

KamDoy Rx Skin Emulsion

Primary DI
00315455956612
Brand
KamDoy Rx Skin Emulsion
Company
ALVIX LABORATORIES, LLC
Model
FP1012-1
Device description
KamDoy Rx Skin Emulsion is indicated as a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. KamDoy Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.
Published
2020-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K141637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141637000SPB SKIN EMULSIONBiotd S.A.2015-06-03FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00315455956612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00315455956612003154559566123154559566120315455956612

GMDN Terms#

Term, Definition table
TermDefinition
Skin osmotic dressing, non-sterileA non-sterile substance (e.g., ointment, cream, spray, impregnated material) intended to be topically applied to the skin (e.g., face, eyelids, extremities) and containing compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to expedite wound healing and skin re-epithelialization primarily through osmotic properties which absorb and retain water to create a moist environment; it does not include antimicrobial agents. It may be used to treat superficial and/or deep wounds (e.g., abrasions, lacerations, burns, surgical wounds, decubitus sores, ulcers). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962445925
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00315455957039AzaDrox Rx Wound GelFP1020-12020-05-20
00315455956834BasaDrox Rx Wound GelFP1019-202020-03-10

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00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29