Label: ABSORPTION PHARMACEUTICALS- lidocaine gel

  • NDC Code(s): 55636-101-01
  • Packager: Absorption Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active Ingerdient

    Lidocaine 10 mg

  • Purpose:

    Male Genital Desensitizer

  • Use:

    Help in temporarily slowing the onset of ejaculation

  • Warnings:

    For external use only

  • Do not use if:

    You or your partner are allergic to lidocaine or topical anesthetics.

  • When using this product:

    Avoid contact with eyes

    Do not spray on broken skin or sensitive skin

  • Stop use and ask a doctor

    This product is used and does not provide relief. Premature ejaculation 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 immediately

  • Ask a doctor or pharmacist before use

    If you have liver problems

    If your partner, or may be pregnant

  • Directions

    Gently shake bottle. Hold upright and press pump until spray dispenses. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 10 minutes before sexual intercourse or use ad director by a doctor.

    Wash product off after intercourse.

  • Other information

    Store at 68 - 77° F (20 -25° C)

  • Inactive ingredient

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer

    Cetearyl Alcohol

    Citric Acid

    Ceteareth-20

    Dimethicone

    Farnesol

    Fragrance

    Glycerin

    Hydrogenated Polyisobutene

    Macadamia Ternifolia Seed Oil

    Panthenol

    Phenoxyethanol

    SD Alcohol 40-B

    Sodium Hydroxide

    Soy lecithin

    Stearoxytrimethylsilane

    Stearyl Alcohol

    Thymol

    Vitamin E Acetate

    Water

  • PRINCIPAL DISPLAY PANEL

    The Coach

  • INGREDIENTS AND APPEARANCE
    ABSORPTION PHARMACEUTICALS 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55636-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MACADAMIA TERNIFOLIA SEED OIL (UNII: 515610SU8C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    THYMOL (UNII: 3J50XA376E)  
    CETEARETH-20 (UNII: YRC528SWUY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    FARNESOL (UNII: EB41QIU6JL)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55636-101-012.6 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01112/17/2024
    Labeler - Absorption Pharmaceuticals LLC (014937753)
    Registrant - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(55636-101)
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