Label: MASSAGE MEN GEL MAX SIZE- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 1, 2021

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  • Active Ingredient

    Benzocaine 5%

  • Purpose

    Male Genital Desensitizer

  • Uses

    • helps in the prevention of premature ejaculation
    • helps in temporarily prolonging the time until ejaculation
  • Warning

    For external use only.

  • When using this product

    Avoid contact with the eyes.

  • Stop use and ask doctor

    • Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
    • If you or your partner develop rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a 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

    • apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse.
    • use only on intact, non-inflamed skin
    • allow gel to dry prior to intercourse
    • not suitable for oral use
    • use as directed, not more than four times per day
  • Other information

    • Store between 20-25°C (68-77°F)
    • Compatible with latex condoms
    • Children resistant closure. Instructions for opening are included in the leaflet
    • Read the enclosed leaflet to achieve best results
  • Inactive Ingredients

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

  • Package Label

    Outer boxLabel

  • INGREDIENTS AND APPEARANCE
    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)
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