NDC 73115-000 Skyn Endurance Delay For Men

Lidocaine

NDC Product Code 73115-000

NDC Code: 73115-000

Proprietary Name: Skyn Endurance Delay For Men 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: Lidocaine 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.

NDC Code Structure

  • 73115 - Sxwell Usa, Llc
    • 73115-000 - Skyn Endurance Delay For Men

NDC 73115-000-01

Package Description: 1 BOTTLE in 1 BOX > 5.1 mL in 1 BOTTLE

NDC Product Information

Skyn Endurance Delay For Men with NDC 73115-000 is a a human over the counter drug product labeled by Sxwell Usa, Llc. The generic name of Skyn Endurance Delay For Men is lidocaine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sxwell Usa, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Skyn Endurance Delay For Men 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.

  • LIDOCAINE 125 mg/mL

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.

  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ARGININE (UNII: 94ZLA3W45F)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Sxwell Usa, Llc
Labeler Code: 73115
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 06-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Skyn Endurance Delay For Men 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 Ingredients

Lidocaine USP (12.5%) (Approximately 10 mg Per Spray)

Purpose

Male Genital Desensitizer

Uses

• Helps in temporarily prolonging the time until ejaculation.


• Helps in the prevention of premature ejaculation.

Warnings

For external use only

Do Not Use

This product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredients. Do not use on broken or inflamed skin.

When Using This Product

Avoid contact with eyes.

Stop Use And Ask A Doctor If

• This product, used as directed, does not provide relief, discontinue use and consult a doctor. Premature ejaculation may be due to a condition requiring medical supervision.


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

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor.


• Wash product off after intercourse.

Other Information

• Do not use if temper evident tab is damaged.


• The package is child resistant.


• Store at room temperature (68-77F).

Inactive Ingredients

Isopropyl Myristate, L-Arginine, Peppermint Oil, Phenoxyethanol.

* Please review the disclaimer below.

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