Label: PROLONG PLUS- benzocaine cream

  • 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 December 19, 2017

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  • ACTIVE INGREDIENT

    Benzocaine - 7.5%

  • PURPOSE

    Male Genital Desensitizer

  • INDICATIONS & USAGE

    Helps in temporarily slowing the onset of ejaculation.

  • WARNINGS

    • 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.
    • For external use only.
    • Avoid contact with eyes.
    • Discontinue use if you or your partner develops rash or irritation, such as burning or itching.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
    • If this product, used as directed, does not provide relief, discontinue use and consult a doctor.
  • DOSAGE & ADMINISTRATION

    • Apply a small amount to head and shaft of penis before intercourse or use as directed by a doctor.
    • Rub product into the skin of the penis until it is absorbed.
    • Remove any excess to avoid any unwanted numbing before intercourse.
    • Wash product off after intercourse.
  • OTHER SAFETY INFORMATION

    • Store at room temperature 20°-25°C (68°-77°F).
    • Tamper-Evident: Do not use if seal under cap is broken or missing.
  • INACTIVE INGREDIENT

    Carbomer, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Panax Ginseng Root Extract, Propylene Glycol, Propylparaben, Purified Water (Aqua), Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    1033007 (1)

  • INGREDIENTS AND APPEARANCE
    PROLONG PLUS 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69797-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE4.2 g  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    AMERICAN GINSENG (UNII: 8W75VCV53Q)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69797-104-0156 g in 1 TUBE; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34812/19/2017
    Labeler - WSM Investment LL. Topco Sales (040346439)
    Establishment
    NameAddressID/FEIBusiness Operations
    WSM Investment LLC. Topco Sales040346439manufacture(69797-104)
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