Label: BOY BUTTER DESENSITIZING LUBRICANT- benzocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active Ingredient:

    Benzocaine 7.5%

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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 advancer 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:

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  • Questions or Comments:

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

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  • PRINCIPAL DISPLAY PANEL

    Placeholder Text

    BB_ExtremeH2O_9oz_label

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  • INGREDIENTS AND APPEARANCE
    BOY BUTTER  DESENSITIZING LUBRICANT
    benzocaine cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24488-042
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 73.9395789 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CYCLOMETHICONE 5  
    PROPYLENE GLYCOL  
    GLYCERYL MONOSTEARATE  
    MINERAL OIL  
    SHEA BUTTER  
    TRICAPRYLIN  
    COCONUT OIL  
    GLYCERIN  
    TROLAMINE  
    CARBOMER HOMOPOLYMER TYPE C  
    ALOE VERA LEAF  
    .ALPHA.-TOCOPHEROL ACETATE  
    METHYLPARABEN  
    DIAZOLIDINYL UREA  
    PROPYLPARABEN  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24488-042-82 266 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 09/25/2012
    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(24488-042)
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