Joint and Muscle Pain

Description

The SPL code for the product is 34089-3. The product is represented visually by an image labeled "tube_shk10_1.jpg," which is in JPEG format. The image depicts the tube label associated with the product.

Uses and Indications

This drug is indicated for the temporary relief of minor pain in muscles and joints associated with conditions such as backache, arthritis, bruises, and sprains.

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

Dosage and Administration

For adults and children over the age of 2, the recommended application is to apply the product generously to the affected area. It is important to massage the formulation well into the painful area to ensure optimal absorption and efficacy. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

For children under the age of 2, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a physician for appropriate alternatives or guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Application with a heating pad is prohibited due to the risk of increased heat and potential skin damage.

• The product should not be applied to wounds or damaged skin to prevent irritation and adverse reactions.

• Tight bandaging after use is contraindicated as it may restrict circulation and lead to complications.

• The product is not recommended for children under the age of 2; consultation with a physician is advised in such cases.

Warnings and Precautions

For external use only. This product should not be used in conjunction with a heating pad, nor should it be applied to wounds or damaged skin. It is important to avoid tight bandaging after application to prevent adverse effects.

Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental contact, immediate rinsing with water is recommended.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product must be kept out of reach of children. In cases of ingestion, it is imperative to seek medical assistance or contact a poison control center immediately.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not be used in conjunction with a heating pad. It is contraindicated for application on wounds or damaged skin, and patients are advised against tightly bandaging the area after use.

Contact with the eyes must be avoided, as it may lead to adverse effects. If a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is essential to discontinue use and consult a physician.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a poison control center without delay.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Joint and Muscle Pain (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over the age of 2 may apply the product generously to the affected area, ensuring it is massaged well into the painful area. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

For children under the age of 2, the product is not recommended, and consultation with a physician is advised prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a poison control center.

Geriatric Use

There is no specific information available 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 menthol cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information regarding the use of menthol cream in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers about the use of this product. The potential effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to mitigate potential risks to the patient.

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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only and should not be used in conjunction with a heating pad. Patients must be instructed not to apply the product to wounds or damaged skin and to avoid bandaging the area tightly after application.

It is important to inform patients to avoid contact with their eyes. They should be counseled to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Providers should emphasize the necessity of keeping the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

For adults and children over the age of 2, patients should be advised to apply the product generously to the affected area and to massage it well into the painful area. They may repeat this application as necessary, but not more than 3 to 4 times daily. For children under the age of 2, it is crucial to advise against use and to recommend consulting a physician.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically. For adults and children over the age of 2, it is recommended to apply generously to the affected area and massage well into the painful area, with a maximum frequency of 3 to 4 times daily as needed. For children under the age of 2, use is not advised, and consultation with a physician is necessary.

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 Joint and Muscle Pain, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)