Label: PREBOOST- benzocaine liquid

  • NDC Code(s): 69681-432-10
  • Packager: The Female Health Company d/b/a Veru Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 7, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzocaine USP 4%

  • Purpose

    Male Genital Desensitizer

  • Use

    Helps in temporarily prolonging time until 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.

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

    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 head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.

  • Inactives

    Purified water, Ethyl Alcohol (SDA 40B), Propylene Glycol

  • PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box

    Clinically Proven to Make Sex Last Longer

    PREBOOST®
    KEEP IT GOING

    10 Single-Use Wipes
    Male desensitizing wipes for
    prolonging the time until ejaculation

    H Fisch MD
    Created by Dr. Harry Fisch, Named
    "One of America's Best Doctors"

    PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box
  • INGREDIENTS AND APPEARANCE
    PREBOOST 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69681-432
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    water (UNII: 059QF0KO0R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69681-432-1010 in 1 BOX04/05/2017
    11.2 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2015
    Labeler - The Female Health Company d/b/a Veru Healthcare (055300578)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69681-432)
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