Eroxon

Primary DI
00079255499990
Brand
Eroxon
Company
Lil' Drug Store Products, Inc.
Model
99990
Catalog number
99990
Device description
Eroxon is a clinically proven gel treatment for adult men with erectile dysfunction, or ED, which is the inability to get or keep an erection sufficient for satisfactory sexual activity.
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220078000EroxonFutura Medical Developments Limited2023-06-09QWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792554999908PrimaryGS10
00079255499990Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792554999908007925549999087925549999080792554999908
00079255499990000792554999900792554999900079255499990

GMDN Terms#

Term, Definition table
TermDefinition
Penile cooling/warming gelA gel/jelly-like substance intended to be applied to the head of the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for sexual intercourse. The gel stimulates erection by providing a cooling effect as the volatile components (e.g., alcohol, water) evaporate, followed by a warming effect due to the body’s efferent response (thermoregulation), resulting in increased blood flow to the penis. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093103646
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792554999908Eroxon99990999902024-10-21
00792554902007SKYN210100902002022-09-12
00792554902014SKYN210120902012022-09-12
00792554902021SKYN210124902022022-09-12
00792554903004Lifestyles832389903002022-09-12
00792554903028Lifestyles833042903022022-09-12
00792554903035Lifestyles832436903032022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00307663076091EroxonHaleon US Holdings LLCQWW2025-04-01
00307663075896EroxonHaleon US Holdings LLCQWW2025-04-01
00792554999908EroxonLil' Drug Store Products, Inc.QWW2024-10-21
00307663074806EroxonHaleon US Holdings LLCQWW2024-09-26