NDC 70000-0037 Lidocaine

Burn Relief

NDC Product Code 70000-0037

NDC CODE: 70000-0037

Proprietary Name: Lidocaine 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: Burn Relief 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

  • 70000 - Cardinal Health - Leader

NDC 70000-0037-1

Package Description: 127 g in 1 CAN

NDC Product Information

Lidocaine with NDC 70000-0037 is a a human over the counter drug product labeled by Cardinal Health - Leader. The generic name of Lidocaine is burn relief. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Cardinal Health - Leader

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.

Lidocaine 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 .64 g/127g

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.

  • WATER (UNII: 059QF0KO0R)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPANE (UNII: T75W9911L6)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • BUTANE (UNII: 6LV4FOR43R)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)

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: Cardinal Health - Leader
Labeler Code: 70000
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: 02-15-2020 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.

Lidocaine 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 0.5%

Purpose

External analgesic

Uses

  • For temporary relief of pain and itching associated with:sunburnminor cutsscrapesminor burnsinsect bitesminor skin irritations

Warnings

For external use only.

Flammable:

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do Not Use

In large quantities, particularly over raw surfaces or blistered areas.

When Using This Product

  • Do not get into eyesask a doctor before using on children under 2 years of age

Stop Use And Ask A Doctor If

  • Condition gets worsesymptoms last more than 7 days or clear up and occur again in a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Center right away.

Directions

  • Shake can wellfor adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailyfor children under 2 years of age: consult a doctorto apply to face, spray in palm of hand and gently apply

Other Information

Store between 20°C to 25°C (68° to 77°F)

Inactive Ingredients

Aloe barbadensis leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerin, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Questions?

Call 1-866-964-0939

* Please review the disclaimer below.