FDA.reportPublic FDA data

JO H2O - Original - Lubricant 2 floz / 60 mL

Primary DI
10796494000356
Brand
JO H2O - Original - Lubricant 2 floz / 60 mL
Company
CC Wellness LLC
Model
40034
Device description
Water-Based Personal Lubricant
Published
2022-09-08
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
NUCLubricant, Personal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796494000356PackageGS112In Commercial Distribution
00796494000359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079649400035610796494000356
00796494000359007964940003597964940003590796494000359

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA 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. 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
false
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
00796494003336Romantix Lube It Silicone lube 4oz705012023-05-12
00796494408292LL - 3X Anal International - 8oz / 240mL40829-INT2026-05-05
00796494408513LL Pickle Lubricant 8oz408512026-04-23
00796494701614LL Pickle Lubricant 10mL Foil701612026-04-23
00796494001059JO - Champagne Flavored Lubricant - 2 floz 60 mL420152022-09-14
00796494420515JO - Lubricant - Bake Shoppe - Orange Creampuff- 2oz420512026-01-23
00796494420522JO - Lubricant - Bake Shoppe - Frosted Cupcake - 2oz420522026-01-23
00796494420539JO - Lubricant - Bake Shoppe - Peach Cobbler - 2oz420532026-01-23
00796494750193JO - Foil - Bake Shoppe - Orange Creampuff - 5ml750192026-01-23
10796494420512JO - Lubricant - Bake Shoppe - Orange Creampuff- 2oz420512026-01-23
10796494420529JO - Lubricant - Bake Shoppe - Frosted Cupcake - 2oz420522026-01-23
10796494420536JO - Lubricant - Bake Shoppe - Peach Cobbler - 2oz420532026-01-23
10796494750190JO - Foil - Bake Shoppe - Orange Creampuff - 5ml750192026-01-23
00796494407769LubeLife - Water-based 8oz - Retail - 3pk40776R2026-01-16
00796494407899LubeLife - Strawberry 8oz - Retail - 3pk40789R2026-01-16
07964944077692LubeLife - Water-based 8oz - Retail - 3pk40776R2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pk40789R2025-07-22
00796494006146Beacon Wellness Fertility Lubricant 4oz723152026-01-07
30796494006147Beacon Wellness Fertility Lubricant 4oz723152026-01-07
00796494003824The Honey Pot - Vanilla - USDA Organic - Lubricant - 2 floz / 60 mL722722023-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
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
08032595872429REVAREEFARMA DERMA SRLNUC2025-06-26
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01
00050428111291CVS Mess free liquidGLOBAL PROTECTION CORP.NUC2025-01-06