NDC 27854-311 Flanax Back Pain Relief

Lidocaine

NDC Product Code 27854-311

NDC CODE: 27854-311

Proprietary Name: Flanax Back 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

  • 27854 - Belmora Llc

NDC 27854-311-01

Package Description: 1 PATCH in 1 POUCH > .24 g in 1 PATCH

NDC Product Information

Flanax Back Pain Relief with NDC 27854-311 is a a human over the counter drug product labeled by Belmora Llc. The generic name of Flanax Back Pain Relief is lidocaine. The product's dosage form is patch and is administered via topical form.

Labeler Name: Belmora Llc

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.

Flanax Back 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 4 g/100g

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.

  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • KAOLIN (UNII: 24H4NWX5CO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • 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: Belmora Llc
Labeler Code: 27854
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: 02-01-2020 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.

Flanax Back Pain Relief Product Label Images

Flanax Back 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 Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

​Warnings

For external use onlyDo not use if pouch is damaged or opened.Do not use • More than 1 patch on your body at a time or on cut, irritated or swollen skin • On puncture wounds • For more than one week without consulting a doctorWhen using this product• Use only as directed. Read and follow all directions and warnings on this pouch• Rare cases of serious burns have been reported with products of this type• Do not apply to wounds or damaged, broken or irritated skin• Do not allow contact with the eyes and mucous membranes• Do not bandage tightly or apply local heat (such as heating pads) to the area of use• Do not use at the same time as other topical analgesics• Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can    produce serious adverse effects if a child or pet chews or ingests this patchStop use and ask a doctor if• Condition worsens • Redness is present • Irritation develops• Symptoms persist for more than 7 days or clear up and occur again within a few days• You experience signs of skin injury, such as pain, swelling, or blistering where the product was appliedIf pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years: • Clean and dry affected area • Carefully remove backing film from patch • Apply one patch to affected area • Do not use more than 2 patches in 24 hours unless directed by a doctor.Children under 12 years: Ask a doctor.How to apply• Remove backing from patch by firmly grasping both ends and gently pull backing to separate it in the middle.• Carefully remove one portion of backing from patch and apply exposed portion of patch to affected area.• Once exposed portion of patch is positioned, remove remaining backing to completely apply patch to affected area.

Inactive Ingredients

Dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate,tartaric acid, titanium dioxide, tween 80, water

Other

LONGER LASTING PAIN RELIEFLIDOCAINE PATCH√ For back, neck, leg & arm pain relieving ointment on a breathable adhesive pad 1 Patch | 3-15/16” x 5-1/2” (10 cm x 14 cm)Questions/Comments?www.flanax.comCall 1 888 779 2877 9AM-5PM ESTDistributed by: Belmora LLC2011 Crystal Dr. Suite 400, Arlington, VA 22202

* Please review the disclaimer below.