BOTTOMS UP- lidocaine liquid 
WSM Investment LLC dba 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 5%

Anorectal

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

If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

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

1031935

BOTTOMS UP 
lidocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69797-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.4 g  in 68 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPENTYLDIOL (UNII: 19NOL5474Q)  
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69797-103-0168 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
2NDC:69797-103-02186 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/15/2017
Labeler - WSM Investment LLC dba Topco Sales (040346439)
Establishment
NameAddressID/FEIBusiness Operations
WSM Investment LLC. Topco Sales040346439manufacture(69797-103)

Revised: 12/2017
Document Id: 606958bb-33e9-6a69-e053-2991aa0ab0e4
Set id: 606958bb-33e8-6a69-e053-2991aa0ab0e4
Version: 1
Effective Time: 20171215
 
WSM Investment LLC dba Topco Sales