FDA.reportPublic FDA data

RepHresh™ Vaginal Gel Personal Lubricant

Primary DI
00022600019657
Brand
RepHresh™ Vaginal Gel Personal Lubricant
Company
CHURCH & DWIGHT CO., INC.
Model
00022600019657
Published
2018-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K021737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021737000REPHRESH VAGINAL GELColumbia Laboratories, Inc.2002-08-26NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00022600019657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600019657000226000196570226000196570022600019657

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
+1(800)833-9532Consumer.Relations@churchdwight.com

Regulatory Flags#

DUNS number
001211952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00022600947219Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009472192016-10-14
00022600947325Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009473252016-10-13
00022600947400Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009474002016-10-13
00022600980506TROJAN™ NaturaLamb™ Luxury Condoms000226009805062016-10-13
00022600987536TROJAN™ NaturaLamb™ Luxury Condoms000226009875362016-10-13
00022600998440TROJAN™ NaturaLamb™ Luxury Condoms000226009984402016-10-13
00022600000600Trojan All The Feels Variety Pack000226000006002020-06-22
00022600000709Trojan All The Feels Variety Pack000226000007092020-07-29
00022600300007Trojan All the Feels Condom000226003000072020-06-10
00022600999492Trojan Variety Pack000226009994922020-07-15
00726893113985Trojan Ultra Thin Condoms007268931139852020-07-07
00726893113992Trojan Ultra Thin Condom007268931139922020-07-16
00726893114005Trojan Ultra Thin Condom007268931140052020-07-08
00726893114043Trojan Magnum007268931140432020-03-12
00726893114098Trojan Magnum Condom007268931140982020-03-27
00726893114104Trojan Enz007268931141042020-03-20
00726893800014Trojan Ultra Thin Condom007268938000142020-09-28
00726893800021Trojan Ultra Ribbed Condom007268938000212020-09-28
00726893800038Trojan Mangum Condom007268938000382020-09-28
00022600019831TROJAN 100CT BULK MIX000226000198312018-10-30

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