NDC 55700-721 Lidopro Patch

Lidocaine, Menthol, And Methyl Salicylate

NDC Product Code 55700-721

NDC Code: 55700-721

Proprietary Name: Lidopro Patch Additional informationCallout TooltipWhat 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, And Methyl Salicylate Additional informationCallout TooltipWhat 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.


Code Structure
  • 55700 - Quality Care Products, Llc
    • 55700-721 - Lidopro Patch

NDC 55700-721-15

Package Description: 15 POUCH in 1 BOX > 5 PATCH in 1 POUCH > 8500 mg in 1 PATCH

NDC Product Information

Lidopro Patch with NDC 55700-721 is a a human over the counter drug product labeled by Quality Care Products, Llc. The generic name of Lidopro Patch is lidocaine, menthol, and methyl salicylate. The product's dosage form is patch and is administered via topical form.

Labeler Name: Quality Care Products, 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 Additional informationCallout TooltipWhat 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.


Lidopro Patch Active Ingredient(s)

Additional informationCallout TooltipWhat 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 HYDROCHLORIDE 4 mg/100mg
  • MENTHOL 5 mg/100mg
  • METHYL SALICYLATE 4 mg/100mg

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • METHYL ACRYLATE (UNII: WC487PR91H)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • NONOXYNOL-30 (UNII: JJX07DG188)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ACRYLIC ACID (UNII: J94PBK7X8S)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Quality Care Products, Llc
Labeler Code: 55700
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-25-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Lidopro Patch Product Label Images

Lidopro Patch 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%

Menthol 5%

Methyl Salicylate 4%

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:• muscle soreness• strains• sprains• arthritis• simple backache• muscle stiffness• bruises

Warnings

For external use only

Stomach Bleeding Warning

This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you• are age 60 or older• have had stomach ulcers or bleeding problems• take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)• take a blood thinning (anticoagulant) or steroid drug• have three or more alcoholic drinks every day while using this product• take more or for a longer time than directed

Do Not Use

• on the face or rashes; on wounds or damaged skin• in the eyes, mouth, or other mucous membranes• on genitals• with a heating pad• if allergic to any NSAIDS• right before or after heart surgery• any patch from a pouch that has been opened for 7 or more days

Ask A Doctor Before Use If

• you are allergic to topical products• the stomach bleeding warning applies to you• you are taking a diuretic• you have high blood pressure, heart disease, or kidney disease• you are pregnant

When Using This Product

• wash hands after applying or removing patch• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop Use And Consult Your Physician If

• stomach pain or upset gets worse or lasts• rash, irritation, or itching develops• you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)• condition worsens

If Pregnant Or Breast Feeding,

Ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

Directions

Adults 18 years and older:• Apply patch to affected area 1 to 2 times daily or as directed.

Instructions For Use

• clean and dry affected area• open pouch and remove one patch containing medical adhesive backing• remove protective film from both patch and medical adhesive• apply one patch to the affected area of pain and leave in place for 8 to 12 hours• if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours• only use one patch at a time• do not use more than 2 patches per day• wash hands with soap and water after applying or removing patch• reseal pouch containing unused patches after each useChildren under 18 years of age: Do not use

Other Information

• some individuals may not experience pain relief until several minutes or hours after applying the patch• avoid storing product in direct sunlight• protect product from excessive moisture• store at 67-77°F (19-25°C)

Inactive Ingredient

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water

Otc - Questions

Manufactured For:Terrain PharmaceuticalsReno, NV 89501Formulated and Designed in NevadaAssembled in ChinaPatent PendingLidoProTM patchFor questions or comments, call877-985-8377

* Please review the disclaimer below.

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