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

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

  • Active Ingredient:

    Benzocaine 5%

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  • Purpose:

    Male genital desensitizer

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  • 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.
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  • Keep out of reach of children

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

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  • 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.
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  • 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.
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  • 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

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  • Questions or Comments:

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

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  • PRINCIPAL DISPLAY PANEL

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    H20Ex16Jar

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  • INGREDIENTS AND APPEARANCE
    BOY BUTTER  EXTREME H2O DESENSITIZING LUBRICANT
    benzocaine cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24488-003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 34.05 g  in 454 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24488-003-70 454 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 06/27/2011
    Labeler - Boy Butter Lubes (961956229)
    Registrant - Creation's Garden Natural Products (961956229)
    Establishment
    Name Address ID/FEI Business Operations
    Creation's Garden Natural Products 961956229 manufacture
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