Triceptin

Lidocaine / Menthol / Methyl Salicylate

Sola Pharmaceuticals
Human Otc Drug
NDC 70512-017

Triceptin also known as Lidocaine / Menthol / Methyl Salicylate is a human otc drug labeled by 'Sola Pharmaceuticals'. National Drug Code (NDC) number for Triceptin is 70512-017. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Triceptin drug includes Lidocaine - 40 mg/g Menthol - 10 mg/g Methyl Salicylate - 20 mg/g . The currest status of Triceptin drug is Active.

Drug Information:

Drug NDC:	70512-017
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:	Triceptin
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 / Methyl Salicylate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Sola Pharmaceuticals
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/g MENTHOL - 10 mg/g METHYL SALICYLATE - 20 mg/g
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:	05 Dec, 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:	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:	SOLA Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2623473
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.
UPC:	0370512017156
UPC stands for Universal Product Code.
NUI:	N0000175682 M0000897 N0000175426 N0000175976
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	98PI200987 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 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
70512-017-15	3 POUCH in 1 BOX (70512-017-15) / 5 g in 1 POUCH	05 Dec, 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.

Other medicines with the same generic name

Triceptin

Lidocaine / Menthol / Methyl Salicylate

Patch
SOLA Pharmaceuticals
NDC: 70512-017

Purpose:

Purpose topical anesthetic

Purpose topcial analgesic

Product Elements:

Triceptin lidocaine / menthol / methyl salicylate lidocaine lidocaine methyl salicylate salicylic acid arnica montana flower propylene glycol titanium dioxide water dihydroxyaluminum aminoacetate edetate disodium glycerin mineral oil polyacrylic acid (250000 mw) povidone k90 sodium polyacrylate (2500000 mw) hydroxyacetophenone kaolin tartaric acid menthol menthol polysorbate 80

Indications and Usage:

Use 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 a nsaid, which may cause stomach bleeding. the chance is small, but higher if you are aged 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 steroidal drug have three or more alcholic drinks every day while using this product take more or for a longer time than directed

Do Not Use:

When Using:

When using this product use only as directed read and follow all directions and warnings on this carton do not allow contact with the eyes do not use at the same time as other topical analgesics do not bandage tightly or apply local heat (such as heating pads) to the area of use do no microwave dispose of used patch in manner that always keeps product away from children and pets. used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Dosage and Administration:

Directions adults, or children over the age of 12: clean and dry affected area. carefully remove backing from patch starting at a corner. apply sticky side of patch to affected area 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 unnsed patches immediately after each use. children under 12 years of age: do not use.

Stop Use:

Stop use and consult 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 stomach pain or upset gets worst or lasts you feel faint, vomit blood, or have bloody or black stools (these are signs or stomach bleeding).

Package Label Principal Display Panel:

âmanufactured for: sola pharmaceuticals llc baton rouge, la 70810 www.solameds.us made in china triceptin topical pain patch for temporary pain relief ndc 70512-017-15 qty: 15 patches (5 per resealable pouch) x 3 triceptin box

Further Questions:

Questions or comments? 866-747-7365

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.