Label: HERBASOUL MALE GENITAL DESENSITIZER CREAM - benzocaine cream

  • NDC Code(s): 50664-100-36
  • Packager: Bodon Med Laboratories Ltd.
  • 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 February 23, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                                                                   Purpose

    Benzocaine 4.5 percent .......................................................................Male Genital

                                                                                                                     Desensitizer

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  • PURPOSE

    Uses

    For temporary male genital desensitization, helping to slow the onset of ejaculation.


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  • WARNINGS

    Warnings

    External use only.

    Premature ejaculation may be due to a condition requiring medical supervision.

    If this product, used as directed, does not provide relief, discontinue use. If symptoms persist,

    consult a doctor.







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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    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.


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  • STORAGE AND HANDLING



    Other Informations

    Store below 35 celius

    Single use only sachets
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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Fragrance, Glycerin, Paraffin Liquid, Paraffin wax, Stearic Acid.

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  • DESCRIPTION

    Manufactured By: Bodon Med Laboratories LTD.

    Street Address

    Tripoli Postal Code

    www.herbasoul.com

    Made in Lebanon

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  • PRINCIPAL DISPLAY PANEL

    This unit not labeled for retail sale

    Herbasoul

    Natural Herbal Care 

    Male Genital Desensitizer Cream

    Net Wt. 0.036 oz  (1 g)

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  • INGREDIENTS AND APPEARANCE
    HERBASOUL MALE GENITAL DESENSITIZER CREAM 
    benzocaine cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50664-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 4.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50664-100-36 5 in 1 CARTON
    1 1 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 02/23/2010
    Labeler - Bodon Med Laboratories Ltd. (557643207)
    Registrant - Bodon Med Laboratories Ltd. (557643207)
    Establishment
    Name Address ID/FEI Business Operations
    Bodon Med Laboratories Ltd. 557643207 manufacture
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