Label: MALE DESENSITIZER PLEASURE BALM- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 31, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Benzocaine 3.0% Male genital Desensitizer

    Uses: Helps in the prevention of premature ejaculation

    Keep out of reach of children. If swallowed, seek medical assistance or contact a Poison Control Center

    Discontinue use and consult a doctor if

    This product used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.

    You or your partner develop a rash or irritation, such as burning or itching.

    Warnings

    For external use only

    Avoid contact with the eyes.

    DIrections

    Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.

    Inactive ingredients:

    Water (Aqua/Eau), Alcohol SD 38B, Propylene Glycol, Polysorbate 20, Carbomer, flavor (Aroma), Sodium Hydroxide, Blue 1 (CI 42090), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

  • PRINCIPAL DISPLAY PANEL

    image of back label

    image of front label

    Kama Sutra

    Pleasure Balm

    Male Genital Desensitizer

    1.7 fl. oz. 50ml

  • INGREDIENTS AND APPEARANCE
    MALE DESENSITIZER  PLEASURE BALM
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75956-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE3.00 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75956-145-021 in 1 BOX
    1NDC:75956-145-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/14/2011
    Labeler - Kama Sutra (053877858)
    Registrant - Kama Sutra (053877858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprise017701475manufacture(75956-145)
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