Label: MANDELAY MALE GENITAL DESENSITIZER- benzocaine gel

  • NDC Code(s): 10705-077-01, 10705-077-28
  • Packager: Majestic Drug Co., INC.
  • 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 November 9, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzocaine 7.5%

  • Purpose

    Male genital desensitizer

  • Uses

    • Helps in temporarily prolonging the time until ejaculation
  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes

    Stop use and ask a doctor if

    • this product, used as directed,does not provide relief. Premature ejaculation may be due to condition requiring medical supervision.
    • you or your partner develop a rash or irritation, such as burning or itching.

    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 2-3 minutes before intercourse, or use as directed by a physician.
    • Wash product off after intercourse.
  • Inactive Ingredients

    Carbowax, Carbomer 974P.

  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

    MANDELAY®

    Climax Control Gel

    NET WT 1.0 OZ. (28.35g)

    PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
  • INGREDIENTS AND APPEARANCE
    MANDELAY   MALE GENITAL DESENSITIZER
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10705-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine2.13 g  in 28.35 g
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10705-077-011 in 1 BOX10/31/1995
    1NDC:10705-077-2828.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34810/31/1995
    Labeler - Majestic Drug Co., INC. (001496777)