NDC 63824-257 Ky Duration For Men

Lidocaine

NDC Product Code 63824-257

NDC CODE: 63824-257

Proprietary Name: Ky Duration 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

NDC 63824-257-01

Package Description: 5 mL in 1 BOTTLE, SPRAY

NDC 63824-257-02

Package Description: 10.8 mL in 1 BOTTLE, SPRAY

NDC Product Information

Ky Duration For Men with NDC 63824-257 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Ky Duration For Men is lidocaine. The product's dosage form is spray, metered and is administered via topical form.

Labeler Name: Rb Health (us) Llc

Dosage Form: Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.

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.

Ky Duration 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 96 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)

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: Rb Health (us) Llc
Labeler Code: 63824
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: 09-01-2016 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: 12-31-2021 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.

Ky Duration 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

Other

Drug Facts

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

Distributed by: Reckitt Benckiser Parsippany, NJ 07054-0224Made in Thailand

Active Ingredient

Lidocaine USP 9.6% (approximately 10mg per spray)

Purpose

Male Genital Desensitizer

Uses

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

Warnings

For external use onlyAvoid contact with the eyes

Otc - Do Not Use

Do not use on broken or inflamed skin.

Ask A Doctor Before Use

  • If your partner is pregnantif you have or have had liver or kidney problems

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are already taking prescribed drugs

When Using This Product

  • Do not get into eyes or nostrilsDo not inhaleDo not exceed a maximum of 20 sprays in 24 hoursAlways use the minimum amount effective for youAllow 5-15 minutes to dry prior to intercoursePremature 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. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.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.

Directions

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

Other Information

  • Storage instructions: Store below 30°C (86°F).The bottle is child resistant. Instructions for opening are included in the leaflet.

Inactive Ingredients

Ethoxydiglycol, Fragrance, Isopropyl Myristate, Stearic Acid

Questions?

1-800-756-5488

* Please review the disclaimer below.