KY DURATION FOR MEN (LIDOCAINE) SPRAY, METERED [RB HEALTH (US) LLC]

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KY DURATION FOR MEN (LIDOCAINE) SPRAY, METERED [RB HEALTH (US) LLC]
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NDC 63824-257-01, 63824-257-02
Set ID 0548403e-f081-4702-8f44-a3844e3b46cf
Category HUMAN OTC DRUG LABEL
Packager RB Health (US) LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine USP 9.6% (approximately 10mg per spray)

  • Purpose

    Male Genital Desensitizer

  • Uses

    • Helps in the prevention of premature ejaculation
    • Helps in temporarily prolonging the time until ejaculation
  • Warnings

    For 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 and consult a doctor.

    Avoid contact with the eyes

    If you or your partner develop rash or irritation, such as burning or itching discontinue use. If symptoms persist, consult a doctor.

    If pregnant or breastfeeding, ask a health professional before use

    Keep out of reach of children.

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

  • Directions

    • Apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse, or use as directed by a doctor
    • Wash product off after intercourse
    • Do not use more than 20 sprays in 24 hours
  • Other information

    • Storage instructions: Store below 30°C (86°F).
    • This product is not compatible with condoms.
    • The bottle is child resistant. Instructions for opening are included in the leaflet.
    • Read the instructions for use and advice inside this pack carefully to achieve best results.
  • Inactive ingredients

    ethoxydiglycol, fragrance, isopropyl myristate, stearic acid

  • Questions?

    1-800-756-5488

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in Taiwan

  • PRINCIPAL DISPLAY PANEL - 5.0 mL Bottle Label

    K♦Y
    DURATION™
    SPRAY FOR MEN

    Male Genital Desensitizer
    Lidocaine USP 9.6% (approximately 10mg per spray)

    LAST LONGER
    STAY IN THE MOMENT

    36 SPRAYS
    0.16 fl oz (5.0 mL)

    PRINCIPAL DISPLAY PANEL - 5.0 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    KY   DURATION FOR MEN
    lidocaine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine96 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-257-015 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2016
    2NDC:63824-257-0210.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34809/01/2016
    Labeler - RB Health (US) LLC (081049410)
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