Label: PREBOOST- benzocaine liquid

  • 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 February 18, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzocaine USP 4.0%

  • 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 develop a rash or irritation, such as burning or itching, discontinue use.
    • If symptoms persist, consult a doctor.
  • 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.

  • 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 – pouch label

    PREBOOST™

    MALE DESENSITIZING WIPES

    Helps in temporarily
    prolonging time until ejaculation

    Developed by Dr. Harry Fisch
    www.preboost.com

    1 single-use premoistened towelette

    Manufactured for 944 Corp
    944 Park Ave, New York, NY 10028 www.preboost.com

    PRINCIPAL DISPLAY PANEL – pouch label
  • PRINCIPAL DISPLAY PANEL – box label

    PREBOOST™

    MALE DESENSITIZING WIPES

    Helps in temporarily prolonging time until ejaculation

    10 single-use
    premoistened towelette

    Developed by Dr. Harry Fisch
    |www.preboost.com

    PRINCIPAL DISPLAY PANEL – box label
  • INGREDIENTS AND APPEARANCE
    PREBOOST 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62192-8500
    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:62192-8500-110 in 1 BOX
    11.2 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/18/2014
    Labeler - 944 Corp (054365072)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(62192-8500)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!