Label: PROLONG- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL

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 August 7, 2016

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  • Drug FactsActive Ingredient

    Benzocaine 5%

  • Purpose

    Male Genital Desensitizer

  • Keep out of reach of children

    Keep out of reach of children.

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

  • Uses

    • Helps in the prevention of premature ejaculation.
  • Warnings

    For external use only.

    • Avoid contact with the eyes.
    • 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.
    • If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
  • Directions

    • Apply a small amount to head and shaft of penis before intercourse.
    • Wash product off after intercourse.
  • Other Information

    Do not use if safety seal under cap is broken or missing.

  • Inactive Ingredients

    Hydroxyethylcellulose, Methylparaben, PEG-8, Propylene Glycol, Propylparaben, Water

  • PROLONG product label

    www.bodyactionproducts.com

    Distributed by:

    Body Action Products

    Lutz, FL 33559

    ACTION BODY PRODUCTS

    Benzocaine Male Genital Desensitizer

    PROLONG

    FOR MEN

    Helps Prolong Sexual Pleasure

    Lubricating Gel

    2 FL OZ (60 ml)

    PMG Prolong

  • INGREDIENTS AND APPEARANCE
    PROLONG 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70742-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE2833 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70742-089-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34806/15/2016
    Labeler - Product Max Group Inc (134893911)
    Registrant - Product Max Group Inc (134893911)
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