Label: PLEASURE BALM KAMA SUTRA- benzocaine gel 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/14

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

  • ACTIVE INGREDIENT

    Active Ingredients           Purpose

    Benzocaine 5.0 %           Male genital desensitizer

    Use

    Helps in temporarily prolonging time until ejaculation

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

    Discontinue use and consult a doctor if

    This product, used as directed does not provide relief

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

    Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    The following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue colored skin as these may be signs of methemoglobinemia

    Warnings

    For external use only

    Do not useif allergic to Benzocaine or any other ingredient in this product

    Safe to use only with latex condoms only

    Premature ejaculation may be due to condition requiring medical supervision

    Consult a doctor prior to use if partner is pregnant

    Avoid contact with eyes: if this happens, rinse thoroughly with water

    Known adverse reactions   Hypersensitivity/allergy has been known to occur, in such a case, discontinue use.

    Directions

    Adults, 18 and over. Apply a small amount to head and shaft of penis 5-10 minutes before intercourse, or use as directed by a health care practitioner. Use the smallest amount to achieve the desired result. Wipe off any excess gel before intercourse. Wash product off after intercourse.

    Inactive Inagredients: Blue 1 (CI 42090), Disodium EDTA, Hydroxyethylcellulose, Mentha Piperita (peppermint oil), PEG-8, Polysorbate 60, Propylene Glycol, Sodium Saccharin, Water (Aqua/Eau), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

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  • PRINCIPAL DISPLAY PANEL

    Carton

    Core packaging

    Kama Sutra

    Pleasure Balm

    Prolonging Gel for Men

    Male Genital Desensitizer

    Gel pour Prolonger pour hommes

    Genitaux Masculin Desensibilisateur


    1.7 fl oz  50 ml

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  • INGREDIENTS AND APPEARANCE
    PLEASURE BALM  KAMA SUTRA
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:75956-147
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    EDETATE DISODIUM  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW)  
    MENTHA PIPERITA  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 60  
    PROPYLENE GLYCOL  
    SACCHARIN SODIUM  
    WATER  
    FD&C YELLOW NO. 5  
    FD&C YELLOW NO. 6  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75956-147-01 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 09/12/2013
    Labeler - Kama Sutra (053877858)
    Registrant - Kama Sutra (053877858)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmetic Technologies 830157012 manufacture(75956-147)
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