NDC 0113-8000 Good Sense Endure

Lidocaine

NDC Product Code 0113-8000

NDC 0113-8000-01

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 6.5 mL in 1 BOTTLE, SPRAY

NDC Product Information

Good Sense Endure with NDC 0113-8000 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Endure is lidocaine. The product's dosage form is spray and is administered via topical form.

Labeler Name: L. Perrigo Company

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Good Sense Endure 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 10 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.

  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

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: L. Perrigo Company
Labeler Code: 0113
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: 05-23-2019 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.

Good Sense Endure 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

Lidocaine USP 8.4% (approximately 10mg per spray)

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 Avoid contact with the eyes Allergy alert: 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

Ask A Doctor Before Use

  • •if your partner is pregnant or breast-feeding •if you have or have had liver or kidney problems

Ask A Doctor Or Pharmacist Before Use If You Are

Already taking prescribed drugs

When Using This Product

  • •do not get into eyes or nostrils •do not inhale •do not exceed a maximum of 20 sprays in 24 hours •always use the minimum amount effective for you •allow 5-15 minutes to dry prior to intercourseCan be used for sexual intercourse and sex play when applied in accordance with the usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.This product is not compatible with condoms.

Stop Use And Ask A Doctor If

  • •this product, used as directed, does not provide relief •you or your partner develop a rash or irritation, such as burning or itching •symptoms persist. Premature ejaculation may be due to a condition requiring medical supervision.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •use only as directed •apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse, or use as directed by a doctor •wash product off after intercoursePlease read the instructions for use and advice inside this pack carefully to achieve best results.

Other Information

  • •store at 20-25°C (68-77°F) •the bottle is child resistant. Instructions for opening are included in the leaflet.

Inactive Ingredients

Diethylene glycol monoethyl ether, fragrance, isopropyl myristate, stearic acid, vitamin E

Instructions For Use

  • Male Genital DesensitizerFor Prolonged PleasureSPRAY FOR MENLidocaine (approximately 10mg per spray)Active Ingredient:Lidocaine USP 8.4% (approximately 10 mg per spray)Purpose: Male Genital DesensitizerUses: •Helps in the prevention of premature ejaculation •Helps in temporarily prolonging the time until ejaculationWarnings •For external use only •Avoid contact with the eyesAllergy alert: Do not use this product if you or your partner are allergic (sensitive) to local anesthetics or any of the other listed ingredientsDo not use on broken or inflamed skinAsk a doctor before use •if your partner is pregnant or breast-feeding •if you have or have had liver or kidney problems Ask a doctor or pharmacist before use if you are already taking prescribed drugsWhen using this product: •Do not get into eyes or nostrils •Do not inhale •Do not exceed a maximum of 20 sprays in 24 hours •Always use the minimum amount effective for you •Allow 5-15 minutes to dry prior to intercourse Can be used for sexual intercourse and sex play when applied in accordance with the usage instructions. Only use in accordance with the instructions, seek medical attention immediately in case of overdose.This product is not compatible with condoms.Stop use and ask a doctor if •this product, used as directed, does not provide relief •you or your partner develop a rash or irritation, such as burning or itching •symptoms persist. Premature ejaculation may be due to a condition requiring medical supervision. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222). Directions •Use only as directed •Apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse, or use as directed by a doctor •Wash product off after intercourse •Please read the instructions for use and advice inside this pack carefully to achieve best results Other information •Store at 20-25°C (68-77°F) •The bottle is child-resistant. Please refer to Opening the Child Resistant Closure section on the reverse side of this leaflet for instructions for opening. Inactive ingredients:Diethylene Glycol Monoethyl Ether, Fragrance, Isopropyl Myristate, Stearic Acid, Vitamin E Questions? 1-800-719-92602Q000 00 J1This product is an endurance enhancer which temporarily prolongs the time until ejaculation so he can have more control and prolong pleasure!Opening the Child Resistant ClosureThe spray bottle is fitted with a child resistant lock. Follow the below steps to open the lock and press the pump several times. On first use, it may take up to a few presses to release the product. When using the product next time, you will dispense the right amount quicker.Place index finger and thumb on ribbed collar. Hold collar firmly. Using the opposite hand, place index finger and thumb on ribbed portion of the cap and squeeze. As you squeeze the cap and hold the collar – turn cap counter-clockwise to remove.Pump to release product. Secure cap after use.Applying this ProductEveryone is different. So, for you, maybe it’s 3 sprays or maybe it’s more. It takes time to understand the right amount for you and how to get the most from this product. For the first time, try 3 sprays.Approximately 5-15 minutes prior to intercourse,1.Hold bottle upright 2” to 3” from penis.2.Apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse, or use as directed by a doctor.3.Rub in as required, and then wipe off any excess with a soft, damp cloth prior to intercourse.4.Wash product off after intercourse.Tip 1 – While you are waiting for the spray to take effect, there’s no better time to use your foreplay skills to tease your partner and increase their desire so they are far more likely to climax.Tip 2 – Take control of how long you want to last to get it right for you and your partner. If you didn’t last as long as desired for the previous time, try an extra spray until both of you are happy (not to exceed 10 sprays unless advised by your doctor). Try reducing the number of sprays if you or your partner experience any reduction in sensation. Keep experimenting with number of sprays and waiting time, as it can take a few tries to get the right level for you both.Distributed ByPerrigo®Allegan, MI 49010perrigo.com

* Please review the disclaimer below.

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