NDC 55636-590 Promescent
Lidicaine Spray Topical

Product Information

Promescent is a human over the counter drug product labeled by Absorption. The generic name of Promescent is lidicaine. The product's dosage form is spray and is administered via topical form.

Product Code55636-590
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Promescent
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Lidicaine
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormSpray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Absorption
Labeler Code55636
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part348
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-11-2013
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Promescent?


Product Packages

NDC 55636-590-13

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 1.3 g in 1 BOTTLE, SPRAY

NDC 55636-590-26

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 3.8 g in 1 BOTTLE, SPRAY

NDC 55636-590-52

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 5.4 g in 1 BOTTLE, SPRAY

NDC 55636-590-74

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 7.4 g in 1 BOTTLE, SPRAY

Product Details

What are Promescent Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • LIDOCAINE 10 g/100g - A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • 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)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Promescent Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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




* Please review the disclaimer below.