MASSAGE MEN GEL MAX SIZE- benzocaine gel 
Valley of the Sun Cosmetics LLC

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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Massage Men Gel Max Size

Active Ingredient

Benzocaine 5%

Purpose

Male Genital Desensitizer

Uses

Warning

For external use only.

When using this product

Avoid contact with the eyes.

Stop use and ask doctor

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help, or contact a poison control center right away.

Directions

Other information

Inactive Ingredients

Water (aqua), alcohol denatured, propylene glycol, disodium EDTA, carbomer, eurycoma longifolia (long jack) root extract, sodium hydroxide

Package Label

Outer boxLabel

MASSAGE MEN GEL MAX SIZE 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
EURYCOMA LONGIFOLIA ROOT (UNII: 43B8E2HG8B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
Color    Score    
ShapeROUND (Round Bottle) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76523-063-1515 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/01/2021
Labeler - Valley of the Sun Cosmetics LLC (176470664)
Registrant - Valley of the Sun Cosmetics LLC (176470664)
Establishment
NameAddressID/FEIBusiness Operations
Valley of the Sun Cosmetics LLC176470664manufacture(76523-063)

Revised: 7/2021
Document Id: c6188bb5-e98a-266a-e053-2995a90a5853
Set id: c6188bb5-e989-266a-e053-2995a90a5853
Version: 1
Effective Time: 20210701
 
Valley of the Sun Cosmetics LLC