Label: SKYN ENDURANCE DELAY FOR MEN- lidocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 21, 2021

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

  • Drug Facts

  • Active ingredients

    Lidocaine USP (12.5%) (Approximately 10 mg Per Spray)

    Purpose

    Male Genital Desensitizer

  • Uses

    • Helps in temporarily prolonging the time until ejaculation.
    • Helps in the prevention of premature ejaculation.

  • Warnings

    For external use only

    Do not use

    this product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredients. Do not use on broken or inflamed skin.

    When using this product

    avoid contact with eyes.

    Stop use and ask a doctor if

    • This product, used as directed, does not provide relief, discontinue use and consult a doctor. Premature ejaculation may be due to a condition requiring medical supervision.
    • You or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor.
    • Wash product off after intercourse.

  • Other Information

    • Do not use if temper evident tab is damaged.
    • The package is child resistant.
    • Store at room temperature (68-77F).

  • Inactive ingredients

    Isopropyl Myristate, L-Arginine, Peppermint Oil, Phenoxyethanol.

  • Package Labeling:

    Outer PackageInner PackageBox

  • INGREDIENTS AND APPEARANCE
    SKYN ENDURANCE DELAY FOR MEN 
    lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73115-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE125 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ARGININE (UNII: 94ZLA3W45F)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73115-000-011 in 1 BOX06/01/2019
    15.1 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2019
    Labeler - Sxwell USA, LLC (080650902)