Solid Roots Roll-on Relief

Description

The SPL Code for this product is 34089-3. The labeling consists of a multi-layer design, which includes Page 1, Page 2, and Page 3, all of which are integral components of the peel-back label.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with bruises, sprains, arthritis, and strains.

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

Dosage and Administration

For adults and children aged twelve years and older, the recommended application is to the affected area no more than ten times per day, as needed for pain relief. It is essential to ensure that the application does not exceed this frequency to avoid potential adverse effects.

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

Contraindications

The product should not be used in the following situations:

• Bandaging should not be performed tightly to prevent potential complications.

• Contact with the eyes must be avoided to reduce the risk of irritation or injury.

• Application to wounds or damaged skin is contraindicated to prevent adverse effects.

• The use of heating pads or other heating devices in conjunction with this product is not recommended due to the potential for increased irritation or adverse reactions.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended systemic absorption or adverse effects.

General precautions must be observed to ensure safe application. Bandaging should not be done tightly, as this may lead to increased local irritation or compromised circulation. Care should be taken to avoid contact with the eyes, as exposure may result in significant irritation or injury. The product should not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to infection. Additionally, the use of heating pads or other heating devices in conjunction with this product is contraindicated, as it may enhance absorption and increase the risk of adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare professionals should advise patients 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 appropriate management and to prevent complications.

Side Effects

For external use only. Patients should 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 occur again within a few days.

Drug Interactions

The use of this medication is contraindicated with heating pads or other heating devices, as the combination may lead to adverse effects. It is essential to avoid such interactions to ensure patient safety and the efficacy of the treatment.

Regarding laboratory test interactions, there are no specific interactions identified. Therefore, routine laboratory tests can be conducted without concern for interference from this medication. However, standard clinical judgment should always be applied when interpreting test results in the context of the patient's overall treatment plan.

Packaging & NDC

Below are the non-prescription pack sizes of Solid Roots Roll-on Relief (menthol 3 percent). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged twelve years and older may apply the medication to the affected area no more than ten times a day as needed for pain relief. For children under twelve years of age, the use of this medication is not recommended without consulting a doctor.

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 currently no information available regarding the use of Solid Roots Roll-On Relief during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals are advised to exercise caution and consider the lack of data when prescribing this product to women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed in the context of individual patient circumstances.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential to assess creatinine clearance to determine the appropriate dosing for these individuals. Additionally, patients with reduced renal function should be monitored closely throughout the treatment course. Renal function tests are recommended prior to initiation and during treatment to ensure safe and effective use of the medication.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and 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 use of the compound in these contexts.

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 instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Patients should be informed not to bandage the area tightly, as this may lead to complications. Additionally, they should be cautioned to avoid contact with the eyes to prevent irritation or injury. It is essential to instruct patients not to apply the product to wounds or damaged skin, as this could exacerbate the condition or lead to adverse effects.

Finally, healthcare providers should emphasize that the product should not be used in conjunction with heating pads or other heating devices, as this may increase the risk of side effects or complications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Users should be aware that the product should be discarded after opening if it is not utilized within a specified time frame, although the exact duration is not provided in the current information.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Solid Roots Roll-on Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)