Lidopro Patch
Lidocaine, Menthol, And Methyl Salicylate
Preferred Pharmaceuticals, Inc.
Human Otc Drug
NDC 68788-7687Lidopro Patch also known as Lidocaine, Menthol, And Methyl Salicylate is a human otc drug labeled by 'Preferred Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Lidopro Patch is 68788-7687. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Lidopro Patch drug includes Lidocaine Hydrochloride - 4 mg/100mg Menthol, Unspecified Form - 5 mg/100mg Methyl Salicylate - 4 mg/100mg . The currest status of Lidopro Patch drug is Active.
Drug Information:
| Drug NDC: | 68788-7687 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Lidopro Patch |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Lidocaine, Menthol, And Methyl Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Preferred Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | LIDOCAINE HYDROCHLORIDE - 4 mg/100mg
MENTHOL, UNSPECIFIED FORM - 5 mg/100mg
METHYL SALICYLATE - 4 mg/100mg
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jun, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Preferred Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1599164
1599302
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | V13007Z41A
L7T10EIP3A
LAV5U5022Y
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Amide Local Anesthetic [EPC]
Amides [CS]
Antiarrhythmic [EPC]
Local Anesthesia [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68788-7687-1 | 15 POUCH in 1 BOX (68788-7687-1) / 5 PATCH in 1 POUCH / 8500 mg in 1 PATCH | 01 Jun, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Purpose topical analgesic
Purpose topical analgesic
Product Elements:
Lidopro patch lidocaine, menthol, and methyl salicylate aluminum hydroxide carboxymethylcellulose sodium, unspecified 2-ethylhexyl acrylate glycerin isopropyl myristate methyl acrylate sodium polyacrylate (8000 mw) nonoxynol-30 polyacrylic acid (250000 mw) polysorbate 80 acrylic acid sorbitan sesquioleate starch, corn talc titanium dioxide water lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous menthol, unspecified form menthol, unspecified form methyl salicylate salicylic acid tartaric acid
Indications and Usage:
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:
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 h
Read more...igh 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.
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:
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.
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
When Using:
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.
Dosage and Administration:
Directions adults 18 years and older: ⢠apply patch to affected area 1 to 2 times daily or as directed.
Stop Use:
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
Package Label Principal Display Panel:
Principal display panel ndc 68788-7687-01 professional use only lidopro ⢠patch transdermal pain relief patch & medical adhesive deep penetrating long lasting soothing 15 patches lidopro patch
Further Questions:
Manufactured for: terrain pharmaceuticals reno, nv 89501 formulated and designed in nevada assembled in china patent pending lidoprotm patch for questions or comments, call 877-985-8377 relabeled by preferred pharmaceuticals, inc.