NDC 41520-789 Careone Lidocaine Pain Relief

Lidocaine

NDC Product Code 41520-789

NDC CODE: 41520-789

Proprietary Name: Careone Lidocaine Pain Relief 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 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

  • 41520 - American Sales Company

NDC 41520-789-91

Package Description: 6 BLISTER PACK in 1 CARTON > 1 PATCH in 1 BLISTER PACK

NDC Product Information

Careone Lidocaine Pain Relief with NDC 41520-789 is a a human over the counter drug product labeled by American Sales Company. The generic name of Careone Lidocaine Pain Relief is lidocaine. The product's dosage form is patch and is administered via topical form.

Labeler Name: American Sales Company

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Careone Lidocaine Pain Relief 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 560 mg/1

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.

  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYVINYL ACETATE (UNII: 32K497ZK2U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • TARTARIC ACID (UNII: W4888I119H)
  • UREA (UNII: 8W8T17847W)

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: American Sales Company
Labeler Code: 41520
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: 07-09-2020 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.

Careone Lidocaine Pain Relief Product Label Images

Careone Lidocaine Pain Relief 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 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Do Not Use

  • •more than 1 patch at a time •on wounds or damaged skin •with a heating pad •if you have ever had an allergic reaction to this product or any of its ingredients

When Using This Product

  • •use only as directed •avoid contact with the eyes, mucous membranes or rashes •do not bandage tightly

Stop Use And Ask A Doctor If

  • •localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering •conditions worsen •symptoms persist for more than 7 days •symptoms clear up and occur again within a few days

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children 12 years of age and over: •clean and dry affected area •remove film from patch and apply to the skin (see illustration) •apply 1 patch at a time to affected area, not more than 3 to 4 times daily •remove patch from the skin after at most 8 hours of applicationChildren under 12 years of age: consult a doctor

Other Information

  • •avoid storing product in direct sunlight •protect product from excessive moisture •store at 20-25°C (68-77°F)

Inactive Ingredients

Carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea

* Please review the disclaimer below.