LIQUID SEX- lidocaine gel 
WSM Investment LLC. Topco Sales

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 2%

Anorectal

For temporary relief of pain, soreness or burning in the perianal area.

Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylparaben, Purified Water (Aqua).

1039093

LIQUID SEX 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69797-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.36 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOPENTYLDIOL (UNII: 19NOL5474Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69797-101-01118 mL in 1 TUBE; Type 0: Not a Combination Product12/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/14/2017
Labeler - WSM Investment LLC. Topco Sales (040346439)
Establishment
NameAddressID/FEIBusiness Operations
WSM Investment LLC. Topco Sales040346439manufacture(69797-101)

Revised: 12/2017
Document Id: 60528224-b0ff-6b38-e053-2a91aa0a18d2
Set id: 60528224-b0fe-6b38-e053-2a91aa0a18d2
Version: 1
Effective Time: 20171214
 
WSM Investment LLC. Topco Sales