NDC 76523-069 Massage Men Gel Max Delay

Benzocaine

NDC Product Code 76523-069

NDC CODE: 76523-069

Proprietary Name: Massage Men Gel Max Delay 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.

Non-Proprietary Name: Benzocaine 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.

Product Characteristics

Shape: ROUND (C48348)

NDC Code Structure

  • 76523 - Valley Of The Sun Cosmetics Llc

NDC 76523-069-15

Package Description: 15 g in 1 BOTTLE, DISPENSING

NDC Product Information

Massage Men Gel Max Delay with NDC 76523-069 is a a human over the counter drug product labeled by Valley Of The Sun Cosmetics Llc. The generic name of Massage Men Gel Max Delay is benzocaine. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug 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.

Massage Men Gel Max Delay Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the 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)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CAFFEINE (UNII: 3G6A5W338E)
  • ALCOHOL (UNII: 3K9958V90M)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PROPANEDIOL (UNII: 5965N8W85T)

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.

Labeler Name: Valley Of The Sun Cosmetics Llc
Labeler Code: 76523
FDA Application Number: part348 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 07-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Massage Men Gel Max Delay Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Benzocaine 7%

Purpose

Male Genital Desensitizer

Uses

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

Warnings

For external use only.

When Using This Product

Avoid contact with the eyes.

Stop Use And Ask Doctor

  • Premature ejacualtion 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. If you or your partner develop rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.

If Pregnant Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply a small amount to the head and shaft of the penis before intercourse or use as directed by a doctor. Wash product off after intercourse.use only on intact, non-inflamed skinallow gel to dry prior to intercoursenot suitable for oral useuse as directed, not more than four times per day

Other Information

  • Store between 20-25°C (68-77°F)Compatible with latex condomsChildren resistant closure. Instructions for opening are included in the leafletRead the enclosed leaflet to achieve best results

Inactive Ingredients

Water (aqua), alcohol denatured, propylene glycol, disodium EDTA, carbomer, caffeine, sodium hydroxide

* Please review the disclaimer below.