MALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]

MALE GENITAL DESENSITIZER STUD 100 (LIDOCANE) SPRAY, METERED [POUND INTERNATIONAL CORP]
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NDC 57707-050-01, 57707-050-02
Set ID d075656e-b13f-4a1d-bbb6-501e642698d5
Category HUMAN OTC DRUG LABEL
Packager Pound International Corp
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient                                                                                    Purpose

    Lidocaine Base  9.6% w/w (approximately 10 mg per spray)                Topical Anesthetic

  • PURPOSE

    Use

    temporarily reduces sensitivity of the penis, which helps to delay ejaculation in cases of over-rapid or premature ejaculation (coming to a climax too quickly)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop and consult a doctor

    if you or your partner develop a rash or irritation, such as burning or itching

    if you do feel unwell or have any unpleasant effects after using the spray

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

  • WARNINGS

    Warnings

    For external use only

    Allergy alert: do not use this product if you or your partner are allergic (sensitive) to local Anesthetics.

    Do not use - on broken or inflamed skin -if your partner is pregnant

    Ask a doctor before use if you have, or ever had, liver or kidney problems

    Ask a doctor or pharmacist before use if you are already taking prescribed drugs

    when using this product

    - do not get into eyes

    - do not inhale

    - do not exceed 24 sprays in 24 hours

  • DOSAGE & ADMINISTRATION

    Directions

    -apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse, or as directed by a doctor

    -wash product after intercourse

    -correct quantity and time of application will be determined by individual requirements and you should always use the minimum effective quantity

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Fragrance, isopropyl myristate, solvent, stearic acid

  • PRINCIPAL DISPLAY PANEL

    Stud 100 Male Genital Desensitizer Spray

    The Delay Spray for Men

    Active ingredient

    Lidocaine Base USP

    9.6% w/w 7/16 fl. oz

    Desensitizer

    Can

  • INGREDIENTS AND APPEARANCE
    MALE GENITAL DESENSITIZER  STUD 100
    lidocane spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57707-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE9.6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57707-050-021 in 1 CARTON03/13/2013
    1NDC:57707-050-0112.5 mL in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/13/2013
    Labeler - Pound International Corp (802685065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaserve (North West) Ltd210141282manufacture(57707-050)

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