PROLONG PLUS- benzocaine cream 
WSM Investment LL. 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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Benzocaine - 7.5%

Male Genital Desensitizer

Helps in temporarily slowing the onset of ejaculation.

Carbomer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Panax Ginseng Root Extract, Propylene Glycol, Propylparaben, Purified Water (Aqua), Triethanolamine.

1033007 (1)

PROLONG PLUS 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69797-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE4.2 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
AMERICAN GINSENG (UNII: 8W75VCV53Q)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69797-104-0156 g in 1 TUBE; Type 0: Not a Combination Product12/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34812/19/2017
Labeler - WSM Investment LL. Topco Sales (040346439)
Establishment
NameAddressID/FEIBusiness Operations
WSM Investment LLC. Topco Sales040346439manufacture(69797-104)

Revised: 12/2017
Document Id: 60b7577d-53aa-4f6f-e053-2991aa0a4480
Set id: 60b7577d-53a9-4f6f-e053-2991aa0a4480
Version: 1
Effective Time: 20171219
 
WSM Investment LL. Topco Sales