LM Plus Relief
Lidocaine and Menthol · Patch · Topical
Contraindications
Plus Relief Patch ® is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the topical amide-like local anesthetic preparations or to any other component of the product.
Warnings
1. Do not use : More than 1 patch on your body at a time or on irritated or swollen skin On wounds, damaged or infected skin On eyes, mouth, genitals, or other mucous membranes With a heating pad 2. Consult physician for children under 12 years of age 3. Stop and consult your prescriber If condition or pain worsens If you are allergic to any of the ingredients in this product If using concurrently with any other external pain-relieving products If you are pregnant, planning to become pregnant, or breastfeeding If symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: Shortness of breath Swelling or numbness of the tongue or throat Severe headache or vomiting Dizziness or faintness Changes in vision or speech Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. General information about the safe and effective use LM Plus Relief Patch ® Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication unless instructed and prescribed by a physician. Do not give this drug to anyone else, even if they have the same condition. This product is intended for use as prescribed by a physician. How should I store LM Plus Relief Patch ® Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Safely discard product after expiration date posted on the product label. Discard patches away from small children or animals. DO NOT use the product after the expiration date printed on the box. What are the active ingredients in LM Plus Relief Patch ® ? The patch consists of 3.5% lidocaine and 7% menthol.
Precautions
Because of the possibility of sedation, patients should be cautioned regarding the operation of heavy machinery or automobiles, and any activities made hazardous by decreased alertness. Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine, because of their inability to metabolize Lidocaine normally. Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Lidocaine. However, this product should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of Lidocaine from increased absorption. LM Plus Relief Patch ® is only recommended for use on intact skin. Eye Exposure: The contact of this product with the eyes, although not studied, should be avoided based on the findings of severe eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over patches is not recommended as this has not been evaluated and may increase plasma Lidocaine levels. DRUG INTERACTIONS Antiarrhythmic Drugs: LM Plus Relief Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When LM Plus Relief Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered. CARC INOGENESIS , MUTAGENESIS , IMPAIRMENT OF FERTILITY : A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of topical lidocaine. The effect of LM Plus Relief Patch ® on fertility has not been studied. PREGNANCY: The safety of LM Plus Relief Patch ® has not been established during pregnancy. There are no well-controlled studies in pregnant women. LM Plus Relief Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician. NURSING MOTHERS The effect of LM Plus Relief Patch ® on the nursing infant has not been evaluated. Caution should be exercised when LM Plus Relief Patch ® is administered to a nursing mother. PEDIATRIC / GERIATRIC USE Safety and effectiveness in pediatric and geriatric patients have not been established. ADVERSE REACTIONS The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of LM Plus Relief Patch ® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.
Side effects
The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of LM Plus Relief Patch ® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.
Drug interactions
Antiarrhythmic Drugs: LM Plus Relief Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When LM Plus Relief Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.
Pregnancy
PREGNANCY: The safety of LM Plus Relief Patch ® has not been established during pregnancy. There are no well-controlled studies in pregnant women. LM Plus Relief Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician.
Pediatric use
Safety and effectiveness in pediatric and geriatric patients have not been established.
Overdosage
There have been no reports of over-dosage with LM Plus Relief Patch ® . Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
Description
Plus Relief Patch ® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C 14 H 22 N 2 O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure: ** Lidocaine ** Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C 10 H 20 O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31 O C to 36 O C and has the following structure: ** Menthol ** LM Plus Relief Patch ® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin. Lidocaine Menthol
How supplied
Plus Relief Patch ® is supplied in the following dosage form: 15 Patches [ (5 per Re-sealable Pouch) x 3 ] Rx Only Manufactured for: AriBrands, LLC 2317 Cotner Ave Los Angeles, CA 90064 310.294.8956 Exclusively Distributed by: Alexso, Inc Los Angeles, CA 90064 NDC: 71436-3571-5 Size: 15 Patches
Label text from the FDA structured product label by ARI BRANDS, LLC (revised Sep 1, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
LM Plus Relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 71436-3571 | Lidocaine 490 mg/1; Menthol 980 mg/1 Patch | ARI BRANDS, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What are the side effects of LM Plus Relief?
The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of LM Plus Relief Patch ® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may… See the full label for the complete list.
Who makes LM Plus Relief?
LM Plus Relief is listed by 1 labeler in the FDA NDC directory, including ARI BRANDS, LLC.