Theracare Pain Relieving Muscle Vanishing Scent

Description

The product is a topical formulation identified by SPL code 34089-3. It contains menthol as the active ingredient and is specifically designed to provide a vanishing scent. The formulation is packaged in a 57 g tube.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate course of action and dosage.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition and causing further injury. The use of a heating pad in conjunction with this product is also contraindicated, as it may lead to increased risk of burns or skin irritation. Additionally, this product should not be used in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a doctor prior to use if there is any redness present over the affected area. When utilizing this product, it is imperative to follow the instructions provided and to avoid contact with the eyes or mucous membranes. Additionally, patients should refrain from applying tight bandages over the treated area.

Patients must be instructed to discontinue use and seek medical advice if excessive skin irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days or resolve only to reappear within a few days.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for children under 12 years of age who have arthritis-like conditions.

Before using this product, patients should consult a doctor if there is redness over the affected area. While using the product, it is crucial to adhere strictly to the directions provided, avoid contact with the eyes or mucous membranes, and refrain from tightly bandaging the area.

Patients are advised to discontinue use and seek medical advice if excessive skin irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Pain Relieving Muscle Vanishing Scent (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a physician prior to use.

For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of TheraCare Pain Relieving Muscle Vanishing Scent during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on the appropriate steps to take.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to use the medication only as directed and to avoid contact with eyes or mucous membranes. It is important to emphasize that they should not bandage the area tightly after application.

Healthcare providers should encourage patients to consult a doctor before use if there is any redness over the affected area. Patients should be instructed to stop using the medication and seek medical advice if they experience excessive skin irritation, if the condition worsens, or if symptoms persist for more than 7 days. Additionally, patients should be advised to discontinue use and consult a doctor if symptoms clear up and then recur within a few days.

Patients must be cautioned against using the medication on wounds or damaged skin, and they should not use it in conjunction with a heating pad. Furthermore, it is essential to inform patients that this medication should not be used on children under 12 years of age who have arthritis-like conditions.

Storage and Handling

The product is supplied in a tube format. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). It is imperative that the product is not used if the tube seal under the cap is broken, as this may compromise the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Theracare Pain Relieving Muscle Vanishing Scent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)