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Questions & Answers
Side Effects & Adverse Reactions
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.
PRECAUTIONS:
Because of the possibility of sedation, patients should be cautioned regarding the operation of serious machinery or automobiles, and activities made hazardous by decreased alertness.
DRUG INTERACTIONS:
No Drug interactions have been assessed with MaL Patch
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Nonclinical toxicity studies to determine the potential of this topical preparation to cause carcinogenicity or mutagenicity have not been performed. The effect of the product on fertility has not been evaluated in animals.
PREGNANCY:
The safety of MaL Patch has not been established during pregnancy. There are no well-controlled studies in pregnant women.
PEDIATRIC / GERIATRIC USE:
Safety and effectiveness in pediatric and geriatric patients have not been established.
NURSING MOTHERS:
The effect of MaL Patch on nursing infants has not been evaluated.
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 MaL 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.
OVERDOSAGE:
There have been no reports of over-dosage with MaL 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
MaL Patch is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact.
History
There is currently no drug history available for this drug.
Other Information
MaL Patch is a prescription topical patch containing 15 articulated patches (5 per resealable pouch x 3 pouches). Lidocaine is present in a 4% concentration and menthol is present in a 5% concentration.
Sources
Mal Manufacturers
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Solubiomix
![Mal (Menthol Lidocaine) Patch [Solubiomix]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mal | Solubiomix
DOSE:
ADMINISTRATION
Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily. MaL Patch should be worn for 8hours at a time and no more than 12 hours within a 24-hour period. Children under 12 years, consult a physician before use.
Clean and dry affected area Open pouch and remove one patch If desired, cut pad to size Remove protective film and apply sticky side directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patches. Do not store patch outside the sealed envelope. Fold used patches so that the adhesive side sticks to itself and safely discard used patches where children and pets cannot get to them.
Instructions for Use: -
Solubiomix
Mal | Foodhold U.s.a. Llc
DISTRIBUTED BY:
Foodhold, U.S.A., LLC
Landover, MD 20785
Made in Korea
![Mal (Menthol Lidocaine) Patch [Solubiomix]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=827f5af2-da4b-4df1-9ff2-d41f9575ff51&name=31960.jpg)
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