Label: KY DURATION FOR HIM- benzocaine gel

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 25, 2022

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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 resistant 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

  • PRINCIPAL DISPLAY PANEL 5.0 mL Can Label

    36
    pumps

    KY®
    EST
    1904

    duration®

    gel for him

    male genital desensitizer
    Benzocaine USP 7%

    latex condom compatible

    don't
    stop

    36 Pumps 0.16 fl oz (5.0 mL)

    PRINCIPAL DISPLAY PANEL 5.0 mL Can Label
  • INGREDIENTS AND APPEARANCE
    KY DURATION FOR HIM 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-683
    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:72854-683-011 in 1 CARTON09/01/2020
    15 mL in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34809/01/2020
    Labeler - RB Health (US) LLC (081049410)
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