NDC 11527-191 Sheffield Lidocaine

Lidocaine

NDC Product Code 11527-191

NDC CODE: 11527-191

Proprietary Name: Sheffield 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: 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

  • 11527 - Sheffield Pharmaceuticals Llc

NDC 11527-191-30

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC Product Information

Sheffield Lidocaine with NDC 11527-191 is a a human over the counter drug product labeled by Sheffield Pharmaceuticals Llc. The generic name of Sheffield Lidocaine is lidocaine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sheffield Pharmaceuticals Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Sheffield 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 40 mg/g

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sheffield Pharmaceuticals Llc
Labeler Code: 11527
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: 12-22-2020 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.

Sheffield 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

Other

Drug Facts

Active Ingredient

Lidocaine  4%

Purpose

Topical anesthetic

Uses

  • Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • On large areas of the body or on cut,irritated or swollen skinon puncture woundsfor more than one week without consultanting a doctor

When Using This Product

Use only as directed. read and follow all directions and warnings on this carton.do notallow contact with the eyesdo not bandage or apply local heat (such as heating pads) to the area of use.

Stop Use And Ask A Doctor If

  • Condition worsenssymptons persist for more than 7 days or clear up and occur again within a few days.If pregnant or breast feeding, ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children And Pets.

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

Directions

  • Adults and children over 12 years: apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour periodChildren under 12 years  or younger: ask a doctor

Other Information

  • Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Polysorbate 80,  Propylene Glycol, Tocopheryl Acetate, Trolamine, Water (purified)

Principal Panel-Tube

Sheffield  NDC 11527-191-304% LidocaineTopical Anesthetic CreamNET WT. 30g (1.06 oz)

Principal Panel - Carton

Sheffield    NDC 11527-191-304% LidocaineTopcial Anestheic Cream NET WT. 30g (1.06 oz)

* Please review the disclaimer below.