KY DURATION FOR MEN (BENZOCAINE) GEL [RECKITT BENCKISER LLC]

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KY DURATION FOR MEN (BENZOCAINE) GEL [RECKITT BENCKISER LLC]
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NDC 63824-259-01, 63824-259-02, 63824-259-03, 63824-259-04, 63824-259-05
Set ID e10445c0-e8ff-47fb-ac45-992950e28ea2
Category HUMAN OTC DRUG LABEL
Packager RB Health (US) LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine USP 7%

  • 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 a 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 a small amount to the head and shaft of the penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.
    • use only on intact, non-inflamed skin
    • allow gel to dry prior to intercourse
    • not suitable for oral use
    • use as directed, not more than four times per day
  • Other information

    • store between 20-25°C (68-77°F)
    • compatible with latex condoms
    • child resistent closure. Instructions for opening are included in the leaflet.
    • read the enclosed leaflet to achieve best results
  • Inactive Ingredients

    carbomer homopolymer type B, polyethylene glycol

  • Questions?

    1-800-756-5488

  • SPL UNCLASSIFIED SECTION

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

    Made in China

  • PRINCIPAL DISPLAY PANEL - 5 mL Can Carton Label

    NEW SMOOTH GEL

    KY®
    DURATION®
    GEL FOR MEN

    Male Genital Desensitizer
    Benzocaine USP 7%

    LAST LONGER
    ENJOY THE MOMENT

    COMPATIBLE WITH
    LATEX CONDOMS

    36 PUMPS
    0.16 FL. OZ. (5.0 mL)

    Principal Display Panel - 5 mL Can Carton Label
  • INGREDIENTS AND APPEARANCE
    KY DURATION FOR MEN 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-259-011 in 1 CARTON03/19/2018
    15 mL in 1 CAN; Type 0: Not a Combination Product
    2NDC:63824-259-042 in 1 CARTON04/16/2018
    2NDC:63824-259-020.5 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:63824-259-051 in 1 PACKET09/01/2018
    3NDC:63824-259-030.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34803/19/2018
    Labeler - RB Health (US) LLC (081049410)
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