FDA.reportPublic FDA data

Exsens Aloe Vera Gel lubrifiant intime

Primary DI
03701411600014
Brand
Exsens Aloe Vera Gel lubrifiant intime
Company
NEO COSMETIQUE
Model
1
Device description
INTENDED USE This Exsens product is a water based intimate lubricant intended for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.DIRECTIONS Apply desired amount. Reapply as desired. This product is compatible with natural rubber latex condoms and polyisoprene male condoms. This product is not compatible with polyurethane condoms. WARNING This product is not a contraceptive and does not contain spermicide. Avoid contact with the eyes. Keep out of reach of children. Use on healthy intimate mucous. If irritation or discomfort occurs discontinue use immediately and consult a physician. Very slippery on surfaces, clean spills immediately.
Published
2020-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163674000Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - RaspberryNeo Cosmetique2017-09-22NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701411600014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701411600014037014116000143701411600014

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33149465105info@neo-cosmetique.fr

Regulatory Flags#

DUNS number
267777424
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701411600021Exsens Raspberry gel lubrifiant intime 12020-03-04

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Primary DI, Brand, Company table
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