NDC 80327-001 Base Numb Topical Anorectal

Lidocaine, Menthol

NDC Product Code 80327-001

NDC CODE: 80327-001

Proprietary Name: Base Numb Topical Anorectal 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, Menthol 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 medication is used to relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. 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

  • 80327 - Joonem Llc

NDC 80327-001-01

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

Base Numb Topical Anorectal with NDC 80327-001 is a a human over the counter drug product labeled by Joonem Llc. The generic name of Base Numb Topical Anorectal is lidocaine, menthol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Joonem Llc

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.

Base Numb Topical Anorectal 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 40 mg/mL
  • MENTHOL 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.

  • ARGININE (UNII: 94ZLA3W45F)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Joonem Llc
Labeler Code: 80327
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: 09-01-2020 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 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.

Base Numb Topical Anorectal Product Label Images

Base Numb Topical Anorectal 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 4%Menthol 1%

Purpose

Topical Analgesic

Indications:

Temporary relieves minor pain

Warnings:

  • Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physicianDo not apply to wounds or damaged skin.Do not bandage tightly. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep Out Of Reach Of Children To Avoid Accidental Ingestion!

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

Directions:

  • Use only as directedadults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailyChildren under 12 years of age: consult a doctor

Other Information:

Store at 20 to 
25 C (68 to 77 F)

Inactive Ingredients:

L-arginine, Sodium Benzoate, Rectified Spirit, Disodium EDTA, Phenoxyethanol, Polysorbate 20, DM Water

* Please review the disclaimer below.