NDC 69664-002 Dynamo Delay Black Label

Lidocaine

NDC Product Code 69664-002

NDC CODE: 69664-002

Proprietary Name: Dynamo Delay Black Label 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

  • 69664 - Momentum Management Llc

NDC 69664-002-01

Package Description: 1 BOTTLE, SPRAY in 1 BOX > 15 mL in 1 BOTTLE, SPRAY

NDC Product Information

Dynamo Delay Black Label with NDC 69664-002 is a a human over the counter drug product labeled by Momentum Management Llc. The generic name of Dynamo Delay Black Label is lidocaine. The product's dosage form is spray and is administered via topical form.

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.

Dynamo Delay Black Label 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.

  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALCOHOL (UNII: 3K9958V90M)

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: Momentum Management Llc
Labeler Code: 69664
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: 01-01-2018 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.

Dynamo Delay Black Label Product Label Images

Dynamo Delay Black Label 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 13%(approximately 10 mg per spray)

Purpose

Topical Anesthetic

Uses

  • For temporary male genital desensitization, helping to slow the onset of ejaculationhelps in temporarily prolonging the time until ejaculationfor reducing oversensitivity in the male in advance of intercourse

Warnings

For external use onl

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If:

This product, used as directed, does not provide relief. 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.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately

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

Inactive Ingredients

Isopropyl Palmitate, SD Alcohol 40B, Stearic Acid

Questions?

310 446 1632 Monday - Friday 9am-5pm(PST)Manufactured forMomentum Management LLC1206 W Jon StTorrance, CA 90502

* Please review the disclaimer below.