NDC 68788-7687 Lidopro Patch

Lidocaine, Menthol, And Methyl Salicylate

NDC Product Code 68788-7687

NDC 68788-7687-1

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

NDC Product Information

Lidopro Patch with NDC 68788-7687 is a a human over the counter drug product labeled by Preferred Pharmaceuticals, Inc.. 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: Preferred Pharmaceuticals, Inc.

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.

Lidopro Patch 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 HYDROCHLORIDE 4 mg/100mg
  • MENTHOL, UNSPECIFIED FORM 5 mg/100mg
  • METHYL SALICYLATE 4 mg/100mg

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.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (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)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • TARTARIC ACID (UNII: W4888I119H)

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: Preferred Pharmaceuticals, Inc.
Labeler Code: 68788
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: 06-01-2020 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.

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

Other

MethemoglobinemiaCases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

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, call877-985-8377Relabeled by Preferred Pharmaceuticals, Inc.

* Please review the disclaimer below.