Total Muscle Relief

Description

TOTAL MUSCLE RELIEF is available in three dosage forms: a 3 oz roll-on, a 4 oz tube, and a 16 oz container. Each formulation is designed for topical application to provide targeted relief for muscle discomfort. The product is formulated to deliver effective relief through its specific composition, ensuring ease of use and convenience in various settings.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backaches, strains, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, the use of the product should be discontinued. Bandaging the area after application is not recommended. Patients should wash their hands with cold water after use and avoid the use of heating pads or devices.

Patients are instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional before using this product.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with the Poison Control Center should be made.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and is flammable; it should be kept away from excessive heat or open flame. Prior to use, patients with sensitive skin should consult a doctor.

While using this product, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is advised that patients wash their hands with cold water after use and avoid the use of heating pads or devices.

Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption or efficacy of the medication, potentially resulting in reduced therapeutic effects or increased risk of adverse reactions.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the product over affected areas up to four times daily, without the need for massage. For children under 2 years of age, 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 the Poison Control Center.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children. Instruct patients that if the medication is accidentally ingested, they should seek medical help or contact the Poison Control Center immediately. It is important for patients to understand the potential risks associated with accidental ingestion and the necessary steps to take in such an event.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored in a cool, dry place to maintain its integrity and effectiveness. Due to its flammable nature, it is imperative to keep the product away from excessive heat and open flames to prevent any hazardous situations.

Once opened, the product must be discarded to ensure safety and compliance with handling guidelines.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. For adults and children aged 2 years and older, a thin film should be applied to the affected areas no more than four times daily, and massage is not necessary. For children under 2 years of age, it is advised to consult a physician before 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 Total Muscle Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)