Label: BONADUR- lidocaine spray

  • 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 November 20, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient (per spray): Lidocaine approx. 10mg

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if

    • You have liver problems.
  • DO NOT USE

    Do not use if:

    • You or your partner are allergic to lidocaine or topical anesthetics.
    • Your partner is or may become pregnant.
  • 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.
  • STOP USE

    Stop use and ask a doctor

    • if you or your partner develop a rash or irritation, such as burning or itching. If symptoms persist, consult a doctor.
    • 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.
  • Warnings:

    For external use only.

    When using this product

    • Do not spray on broken, irritated or sensitive skin.
    • Avoid contact with the eyes.
  • Indications and Usage

    Helps in temporarily slowing the onset of ejaculation.

    Male genital desensitizing spray with lidocaine

  • Directions:

    Remove plastic cap. Press the actuator repeatedly until product dispenses to prime spray pump. Apply 3 or more sprays not to exceed 10 to the head and shaft of the penis 10 minutes before sexual intercourse or use as directed by a doctor. Recommended initial dosage: 3 sprays. Rub BonaDur into the skin of the penis until all of the product is absorbed. Wash product off after intercourse. Replace plastic cap after each use.

  • Other Information:

    Keep away from fire and flame. Store at 20°-25° C (68°-77° F).

  • Inactive Ingredients:

    Ethyl Alcohol, Propylene Glycol, Purified Water, Oil of Peppermint, Citric Acid, Thymol.

  • Questions?

    Phone 1-877-797-2522 within the United States for reporting serious adverse events associated with use of the product.

  • INFORMATION FOR PATIENTS

    To re-order this product or for product information please visit: www.BonaDur.com

  • OTC -Purpose

    Anesthetic - Helps temporarily prolong the time until ejaculation

  • BonaDur ® For Men

    BonaDurMale genital desensitizing spray with lidocaine

    HELPS TEMPORARILY PROLONG THE TIME UNTIL EJACULATION

    RAPID ACTING LIDOCAINE BASED FORMULA

    Net Contents .25fl oz (7.4ml)

  • INGREDIENTS AND APPEARANCE
    BONADUR 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70582-999
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    THYMOL (UNII: 3J50XA376E)  
    SACCHARIN (UNII: FST467XS7D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70582-999-741 in 1 BOX07/24/2015
    110 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/24/2015
    Labeler - WebRx Pharmacy Palace (136202699)
    Establishment
    NameAddressID/FEIBusiness Operations
    WebRx Pharmacy Palace136202699manufacture(70582-999)
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