Label: PROMESCENT- lidicaine spray

  • 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 January 16, 2013

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

  • Active Ingredient (per spray)

    Lidocaine approx. 10mg

  • Purpose

    Anesthetic

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Use:

    Helps 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.
    • Your partner is, or may be pregnant.

    ​Ask a doctor or pharmacist before use if

    • You have liver problems.

    ​When using this product

    • Do not spray on broken, irritated or sensitive skin.
    • Avoid contact with the eyes.

    ​Stop use and ask a doctor

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

    Break front tab first. To unlock, press in special Child Resistant (R) tab in back of the actuator while turning the actuator to the right. Press the actuator down repeatedly until product dispenses to prime spray pump. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 10 minutes before sexual intercourse, or use as directed by a doctor. Recommended Initial Dosage: 3 sprays. Rub Promescent into the skin of the penis until all of the product is absorbed. Wash product off after intersourse. After spraying, turn actuator to the left to lock.

  • Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Dimethicone, Farnesol, Fragrance, Glycerin, Hydrogenated Polyisobutene, Macadamia Ternifolia Seed Oil, Panthenol, Phenoxyethanol, Purified Water (Aqua), SD Alcohol 40-B, Sodium Hydroxide, Soy Lecithin, Stearoxytrimethylsilane, Stearyl Alcohol, Thymol, Tocopheryl Acetate (Vitamin E).

  • Labeling

    Label

    Unit Carton

  • INGREDIENTS AND APPEARANCE
    PROMESCENT 
    lidicaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55636-590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FARNESOL (UNII: EB41QIU6JL)  
    THYMOL (UNII: 3J50XA376E)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55636-590-741 in 1 CARTON
    17.4 g in 1 BOTTLE, SPRAY
    2NDC:55636-590-131 in 1 CARTON
    21.3 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/11/2013
    Labeler - Absorption (014937753)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(55636-590) , label(55636-590) , pack(55636-590)