Label: OMBRE MEN OVERTIME WIPES- benzocaine cloth

  • NDC Code(s): 54723-007-01
  • Packager: Sambria Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • Drug Facts

  • Active ingredient

    Benzocaine USP 7%

  • Purpose

    Male Genital Desensitizer

  • Indication

    For reducing oversensitivity in the male in advance of intercourse,

  • Warnings

    For External Use only. Do not use onbroken or irritated skin.
    When using this avoid contact with eyes.
    Stop and ask doctor if:

    • the product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.
    • you or your partner develop rash or irritation, such as burning or itching.
    • symptoms persist.
  • 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 before intercourse, or use as directed by a doctor. Wash product off after intercourse. Not suitable for oral use. Use as directed, not for use more than four times per day.

  • SPL UNCLASSIFIED SECTION

    For Questions or Comments, visit our website OMBREMEN.COM

  • Inactive ingredients

    Lactic Acid, Phenol, Phenoxyethanol, Ethylhexylglycerin, Polyethylene Glycol, purified water

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    OMBRE MEN OVERTIME WIPES 
    benzocaine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    PHENOL (UNII: 339NCG44TV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-007-0110 in 1 PACKAGE01/01/2022
    13 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2022
    Labeler - Sambria Pharmaceuticals, LLC (078676259)
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