Menthol

Description

Superior Analgesic Liniment is formulated for temporary soothing relief of minor pains associated with muscle aches, arthritis, bruises, and sprains. This product is intended for external use only and is available in a net volume of 3.5 fluid ounces (100 ml). It is manufactured in China and exported by Huayuan Trading Company, Tianjin, China. The U.S. distributor is Superior Trading Company, located in San Francisco, CA 94108, USA. For inquiries, the contact number is (415) 495-7988, and additional information can be found at www.superiortrading.com.

Uses and Indications

This drug is indicated for the temporary relief of minor pains and aches associated with muscles and joints due to fatigue, exertion, strains, bruises, sprains, and arthritis. It provides soothing relief for minor discomfort resulting from muscle aches, arthritis, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area, not exceeding three times daily. It is essential to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, contact with the eyes must be avoided to prevent injury. Tight bandaging is also contraindicated, as it may lead to complications such as impaired circulation.

Warnings and Precautions

For external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

This product is contraindicated for use on wounds or damaged skin. Healthcare professionals should advise patients to refrain from applying the product in such circumstances to prevent potential complications.

Patients are instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Superior Analgesic. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected area no more than three times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy with their healthcare provider.

Lactation

There is no specific information available regarding the use of this drug in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific details regarding overdosage for this medication (SPL code 34088-5), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

Recommended Actions In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive intake of the medication. Symptoms may vary based on the pharmacological properties of the drug and the individual patient's response.

Management Procedures Management of an overdose should be tailored to the individual case. Healthcare professionals may consider the use of activated charcoal if the patient presents within a suitable timeframe and is not at risk of aspiration. Additionally, supportive measures, including intravenous fluids and monitoring of electrolytes, may be warranted based on the patient's condition.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdose management protocols and consult relevant toxicology resources as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should only be applied to intact skin and not on wounds or damaged skin to prevent adverse effects.

Patients should be counseled to monitor their condition closely. They should report to their healthcare provider if their symptoms worsen, persist for more than 7 days, or if symptoms resolve and then recur within a few days. This vigilance is crucial for ensuring appropriate management of their condition.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes, as this could lead to irritation or injury. Patients should also be instructed not to bandage the area tightly after application, as this may affect the product's efficacy and increase the risk of side effects.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, not exceeding 86º F (30º C). Proper storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered via a transdermal route. For adults and children aged 2 years and older, it should be applied to the affected area no more than three times daily. It is contraindicated for use in children under 2 years of age, and consultation with a doctor is advised for this age group.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Superior Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)