Vanishing Scent Muscle Rub Gel

Description

MUSCLE RUB is a topical formulation designed for the relief of muscle discomfort. It is presented in a cream or gel dosage form, allowing for easy application to affected areas. The product is characterized by its specific blend of active ingredients that provide a soothing effect upon application. The formulation is designed to penetrate the skin, delivering relief directly to the source of discomfort. The appearance of MUSCLE RUB is typically a smooth, homogenous mixture, suitable for topical use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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. The application should be performed with clean hands, ensuring that the affected area is dry before applying the medication.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. It should not be used in conjunction with a heating pad, as this may increase the risk of burns or skin damage. Additionally, the product is contraindicated for children aged 12 years or younger with arthritis-like conditions, as safety and efficacy have not been established in this population.

During application, it is essential to avoid contact with eyes or mucous membranes to prevent irritation. Furthermore, tight bandaging should be avoided to ensure proper circulation and prevent skin complications.

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 use on children aged 12 years or younger who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the area.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

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

Side Effects

Patients using this product should be aware of several important safety considerations. This product is intended for external use only and should not be applied to wounds or damaged skin. It is contraindicated for use with a heating pad and should not be used on children under 12 years of age with arthritis-like conditions.

Before using this product, patients are advised to consult a healthcare professional if there is redness over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the area.

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

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients with arthritis-like conditions who are 12 years of age or older should not use this medication. For children under 12 years of age, it is advised to consult a healthcare professional before use.

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.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

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

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 caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center or seek medical help without delay if the substance is ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and provide supportive care as necessary.

Management of overdosage should include the following steps:

1. Immediate Action: If ingestion has occurred, the patient should be taken to a medical facility for evaluation and treatment.

2. Symptom Monitoring: Continuous observation for any signs of toxicity or adverse reactions is crucial.

3. Supportive Care: Treatment should be tailored to the symptoms presented, and supportive measures should be implemented as required.

It is critical for healthcare professionals to remain vigilant and proactive in managing cases of overdosage to ensure patient safety and effective intervention.

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 text.

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 not be applied to wounds or damaged skin, and it should not be used in conjunction with a heating pad.

Patients should be cautioned against using the product on children aged 12 years or younger who have arthritis-like conditions. They should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using the product, patients must be reminded to avoid contact with their eyes and mucous membranes. They should also be informed not to apply tight bandages over the treated area. Lastly, patients should be encouraged to consult a doctor before using the product if there is any redness present over the affected area.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature, maintained between 20°C and 25°C (68°F and 77°F).

For proper inventory management, the lot number and expiration date can be found on the box or the crimp of the tube. It is essential to handle the product with care to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 12 years and older being 3 to 4 times daily to the affected area. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)