Label: MALE GENITAL DESENSITIZER STUD 100- lidocaine spray, metered

  • NDC Code(s): 57707-050-01, 57707-050-02
  • Packager: Pound International Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 01/14

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

  • ACTIVE INGREDIENT

    Active Ingredient                                                                                    Purpose

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

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

    Stop and consult a doctor

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

    if you do not 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

    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

    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 Ingredients

    Fragrance, isopropyl myristate, solvent, stearic acid

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  • PRINCIPAL DISPLAY PANEL

    carton

    image description

    Stud 100 Male Genital Desensitizer Spray

    The Delay Spray for Men

    Active ingredient

    Lidocaine Base USP

    9.6% w/w 7/16 fl. oz.

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  • INGREDIENTS AND APPEARANCE
    MALE GENITAL DESENSITIZER  STUD 100
    lidocane spray, metered
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57707-050
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 9.6 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL MYRISTATE  
    STEARIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57707-050-02 1 in 1 CARTON
    1 NDC:57707-050-01 473 mL in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/13/2013
    Labeler - Pound International Corp (802685065)
    Registrant - FLEET LABORATORIES LTD (217269489)
    Establishment
    Name Address ID/FEI Business Operations
    FLEET LABORATORIES LTD 217269489 manufacture(57707-050)
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