Lidocaine Dry Patch Plus Menthol
Lidocaine 4% And Menthol 1%
Safrel Pharmaceuticals, Llc
Human Otc Drug
NDC 71309-915Lidocaine Dry Patch Plus Menthol also known as Lidocaine 4% And Menthol 1% is a human otc drug labeled by 'Safrel Pharmaceuticals, Llc'. National Drug Code (NDC) number for Lidocaine Dry Patch Plus Menthol is 71309-915. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Lidocaine Dry Patch Plus Menthol drug includes Lidocaine - 40 mg/1 Menthol - 10 mg/1 . The currest status of Lidocaine Dry Patch Plus Menthol drug is Active.
Drug Information:
| Drug NDC: | 71309-915 |
| 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: | Lidocaine Dry Patch Plus Menthol |
| 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 4% And Menthol 1% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Safrel Pharmaceuticals, Llc |
| 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 - 40 mg/1
MENTHOL - 10 mg/1
|
| 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 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: | 15 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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: | part346 |
| 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: | SAFREL PHARMACEUTICALS, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1249758
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175682
M0000897
N0000175426
N0000175976
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 98PI200987
L7T10EIP3A
|
| 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 EPC: | Amide Local Anesthetic [EPC]
Antiarrhythmic [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Local Anesthesia [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Amides [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| 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 |
|---|
| 71309-915-05 | 5 POUCH in 1 BOX (71309-915-05) / 1 PATCH in 1 POUCH | 15 Mar, 2022 | 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 anesthetic uses temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises. warning for external use only 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 doctor when using this product use only as directed. read and follow all directions and warnings on this label. do not allow contact with the eyes 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 or pets. used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. stop 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 applied if pregnant or breast feeding ask a health professional before use. 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 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor inactive ingredients kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide
Product Elements:
Lidocaine dry patch plus menthol lidocaine 4% and menthol 1% lidocaine lidocaine menthol menthol kaolin polysorbate 80 polyacrylic acid (250000 mw) silicon dioxide sodium polyacrylate (2500000 mw) titanium dioxide
Indications and Usage:
Uses temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises. warning for external use only 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 doctor when using this product use only as directed. read and follow all directions and warnings on this label. do not allow contact with the eyes 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 or pets. used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. stop 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
Read more... experience signs of skin injury, such as pain, swelling, or blistering where the product was applied if pregnant or breast feeding ask a health professional before use. 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 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor inactive ingredients kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide
Warnings:
Warning for external use only 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 doctor when using this product use only as directed. read and follow all directions and warnings on this label. do not allow contact with the eyes 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 or pets. used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. stop 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 applied if pregnant or breast feeding ask a h
Read more...ealth professional before use. 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 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor inactive ingredients kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide
Do Not Use:
Warning for external use only 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 doctor when using this product use only as directed. read and follow all directions and warnings on this label. do not allow contact with the eyes 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 or pets. used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. stop 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 applied if pregnant or breast feeding ask a health professional before use. 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 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor inactive ingredients kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide
Dosage and Administration:
Directions: adults and children over 12 years: clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor inactive ingredients kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide
Stop Use:
Stop 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 applied if pregnant or breast feeding ask a health professional before use. 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 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for up to 12 hours children 12 years or younger: ask a doctor inactive ingredients kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide
Package Label Principal Display Panel:
Package / principle label outer box
Package / inner pouch pouch