MANDELAY MALE GENITAL DESENSITIZER (BENZOCAINE) GEL [MAJESTIC DRUG CO., INC.]

MANDELAY MALE GENITAL DESENSITIZER (BENZOCAINE) GEL [MAJESTIC DRUG CO., INC.]
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NDC 10705-077-01, 10705-077-28
Set ID 6fa0273f-d8c7-40df-b179-847b3ffaed2d
Category HUMAN OTC DRUG LABEL
Packager Majestic Drug Co., INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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