FDA.reportPublic FDA data

JO H2O Flavored Chocolate 4oz/120ml

Primary DI
B362401741
Brand
JO H2O Flavored Chocolate 4oz/120ml
Company
United Consortium
Model
40174
Device description
Water-based Personal Lubricant
Published
2018-05-21
Public version status
Update
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
NUCLubricant, Personal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B362401741PackageHIBCC12In Commercial Distribution
B362401740PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA non-sterile substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067692292
Device count
1
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
B362410201JO Gelato Creme Brulee 1oz/30ml410202018-05-21
B362410211JO Gelato Hazelnut Espresso 1oz/30ml410212018-05-21
B362410221JO Gelato Mint Chocolate 1oz/30ml410222018-05-21
B362410231JO Gelato Salted Caramel 1oz/30ml410232018-05-21
B362410241JO Gelato Tiramisu 1oz/30ml410242018-05-21
B362440201JO Gelato Creme Brulee 4oz/120ml440202018-05-21
B362440211JO Gelato Hazelnut Espresso 4oz/120ml440212018-05-21
B362440221JO Gelato Mint Chocolate 4oz/120ml440222018-05-21
B362440231JO Gelato Salted Caramel 4oz/120ml440232018-05-21
B362440241JO Gelato Tiramisu 4oz/120ml440242018-05-21
B362701251JO Gelato Creme Brulee .1oz/3ml701252018-05-21
B362701271JO Gelato Hazelnut Espresso .1oz/3ml701272018-05-21
B362101161JO H2O Flavored Cherry 1oz/30ml101162018-05-21
B362101171JO H2O Flavored Raspberry 1oz/30ml101172018-05-21
B362101181JO H2O Flavored Strawberry 1oz/30ml101182018-05-21
B362101191JO H2O Flavored Watermelon 1oz/30ml101192018-05-21
B362101211JO H2O Flavored Tropical Passion 1oz/30ml101212018-05-21
B362101221JO H2O Flavored Pineapple 1oz/30ml101222018-05-21
B362101231JO H2O Flavored Banana 1oz/30ml101232018-05-21
B362101241JO H2O Flavored Chocolate 1oz/30ml101242018-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00796494404089JO Cumplay 4ozCC Wellness LLCNUC2026-06-02
00087701190797good neighbor pharmacyAmerisourcebergen Drug CorporationNUC2026-06-01
00787651760643AZOi-Health, Inc.NUC2026-05-29
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
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00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
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07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10