Label: BOY BUTTER EXTREME H2O DESENSITIZING LUBRICANT- 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 June 27, 2011

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  • Active Ingredient:

    Benzocaine 5%

  • Purpose:

    Male genital desensitizer

  • Indications:

    Helps in the prevention of premature ejaculation.

    • For temporary male genital desensitization, helping to slow the onset of ejaculation
    • Helps in temporarily slowing the onset of ejaculation
    • For reducing oversensitivity in the male in advance of intercourse.
  • Keep out of reach of children

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

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

    Apply a small amount to head and shaft of penis before intercourse, or use as directed by a physician
    • Wash product off after intercourse.
  • Inactive Ingredients:

    Water, Cyclopentasiloxane, Propylene Glycol, Glyceryl Stearate and PEG-100 Stearate, Paraffinum Liquidum (Mineral Oil), Butyrospermum Parkii (Shea Butter), Tricaprylin, Cocos Nucifera (Coconut) Oil, Glycerin, Triethanolamine, Carbomer, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Methylparaben, Diazolidinyl Urea, Propylparaben, Yellow 5, Fragrance

  • Questions or Comments:

    For questions or comments, please call 1-818-888-6825

  • PRINCIPAL DISPLAY PANEL

    Placeholder Text

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  • INGREDIENTS AND APPEARANCE
    BOY BUTTER  EXTREME H2O DESENSITIZING LUBRICANT
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE34.05 g  in 454 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TRICAPRYLIN (UNII: 6P92858988)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-003-70454 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/27/2011
    Labeler - Boy Butter Lubes (961956229)
    Registrant - Creation's Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creation's Garden Natural Products961956229manufacture
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