FDA.reportPublic FDA data

BioNourish Vaginal Gel

Primary DI
30850014621071
Brand
BioNourish Vaginal Gel
Company
GOOD CLEAN LOVE, INC.
Model
5 mL
Catalog number
200601
Published
2022-04-14
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

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
K193448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193448000BioNourish LubricantGood Clean Love, Inc.2020-03-12NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044065028PackageGS1100In Commercial Distribution
00850044065127PackageGS1100In Commercial Distribution
30850014621071PackageGS1900In Commercial Distribution
00850014621070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044065028008500440650288500440650280850044065028
00850044065127008500440651278500440651270850044065127
3085001462107130850014621071
00850014621070008500146210708500146210700850014621070

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

Contacts#

Phone, Email table
PhoneEmail
541-344-4483info@goodcleanlove.com

Regulatory Flags#

DUNS number
153909531
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
00850014621070Rehydrate Vaginal Gel5 mL2006012022-04-14
00893268000673Regenesis Fertility Lubricant2oz2004022022-04-12
00893268000680Rehydrate Vaginal Gel2oz2006022022-04-14
00893268000802Regenesis Fertility Lubricant5mL2004012023-04-03
00850044065172Naked Coconut1.5oz7006502025-06-24
00850044065219Naked Coconut3ozE700750, C7007502025-06-24
00893268000253BioNude Ultra Sensitive Personal Lubricant3oz2007042022-04-12
00893268000604Almost Naked4oz.2001042016-10-13
00893268000222Restore Moisturizing Vaginal Gel2oz.5001022017-09-25
00893268000109Almost Naked1.5oz.2001052016-10-13
00850014621773Liquid Lubricant5 mL2005002022-05-18
00850014621780Hybrid Lubricant5 mL2005012022-05-18
00893268000260BioNude Ultra Sensitive Personal Lubricant5 mL2007052022-04-12
00893268000710Restore Moisturizing Vaginal Gel5 mL5001012022-04-12
00850014621940Almost Naked Hint of Mint1.69oz7003502023-07-05
00893268000987Almost Naked5ml2001032016-10-13
00850014621568Hybrid Lubricant1.69oz7002502022-05-09
00893268000239Guilty Pleasure / Cinnamon Vanilla1.5oz.2003052016-10-13
00893268000598Guilty Pleasure / Cinnamon Vanilla4oz.2003042016-10-13
00893268000031Guilty Pleasure / Cinnamon Vanilla5ml 2001062016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00796494006160Williams-Trading/Cloud 9 Water-Based 4ozCC Wellness LLCNUC2026-06-02
00796494006177Williams-Trading/Cloud 9 Water-Based 8ozCC Wellness LLCNUC2026-06-02
00796494006184Williams-Trading/Cloud 9 Cum Lubricant 8ozCC Wellness LLCNUC2026-06-02
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
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
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