Promescent

Lidicaine

Absorption
Human Otc Drug
NDC 55636-590

Promescent also known as Lidicaine is a human otc drug labeled by 'Absorption'. National Drug Code (NDC) number for Promescent is 55636-590. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Promescent drug includes Lidocaine - 10 g/100g . The currest status of Promescent drug is Active.

Drug Information:

Drug NDC:	55636-590
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Promescent
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lidicaine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Absorption
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Spray
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	LIDOCAINE - 10 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	11 Jan, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	13 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Absorption
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0345496000029 0355636590266 0355636590747 0355636590525
UPC stands for Universal Product Code.
NUI:	N0000175682 M0000897 N0000175426 N0000175976
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	98PI200987
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Amide Local Anesthetic [EPC] Antiarrhythmic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Local Anesthesia [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Amides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55636-590-13	1 BOTTLE, SPRAY in 1 CARTON (55636-590-13) / 1.3 g in 1 BOTTLE, SPRAY	11 Jan, 2013	N/A	No
55636-590-26	1 BOTTLE, SPRAY in 1 CARTON (55636-590-26) / 3.8 g in 1 BOTTLE, SPRAY	11 Jan, 2013	N/A	No
55636-590-52	1 BOTTLE, SPRAY in 1 CARTON (55636-590-52) / 5.4 g in 1 BOTTLE, SPRAY	11 Jan, 2013	N/A	No
55636-590-74	1 BOTTLE, SPRAY in 1 CARTON (55636-590-74) / 7.4 g in 1 BOTTLE, SPRAY	11 Jan, 2013	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Promescent

Lidicaine

Spray
Absorption
NDC: 55636-590

Purpose:

Purpose anesthetic

Product Elements:

Promescent lidicaine lidocaine lidocaine water carbomer interpolymer type a (allyl sucrose crosslinked) glycerin panthenol citric acid monohydrate polyoxyl 20 cetostearyl ether cetostearyl alcohol dimethicone hydrogenated polybutene (1300 mw) stearoxytrimethylsilane stearyl alcohol macadamia oil .alpha.-tocopherol acetate lecithin, soybean farnesol thymol alcohol phenoxyethanol sodium hydroxide

Indications and Usage:

Use: helps in temporarily slowing the onset of ejaculation.

Warnings:

Warnings: âfor external use only. â âdo not use if â you or your partner are allergic to lidocaine or topical anesthetics. your partner is, or may be pregnant. âask a doctor or pharmacist before use if â you have liver problems. âwhen using this product â do not spray on broken, irritated or sensitive skin. avoid contact with the eyes. âstop 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. ââ

Dosage and Administration:

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.

Package Label Principal Display Panel:

Labeling label

Labeling 10 spray

Labeling 20 spray

Labeling 40 spray

Labeling 60 spray

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.