Soothe

Description

Soothe is a pharmaceutical formulation designed for therapeutic use. It is characterized by its specific molecular composition and intended pharmacological effects. The product is available in a dosage form that facilitates administration and absorption. The appearance of Soothe is consistent with its formulation, ensuring stability and efficacy. Further details regarding its chemical properties, including molecular weight and chemical formula, are integral to understanding its mechanism of action and therapeutic applications.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

Dosage and Administration

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

The application should be performed directly on the affected area, ensuring that the medication is evenly distributed. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

For external use only; this product should be utilized strictly as directed. Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When administering this product, it is crucial to avoid contact with the eyes. Additionally, it should not be applied to wounds or damaged skin, and tight bandaging should be avoided to prevent complications.

This product is flammable; therefore, it must be kept away from fire or flame to mitigate the risk of ignition.

For individuals who are pregnant or breastfeeding, it is recommended to seek guidance from a healthcare professional prior to use to ensure safety for both the mother and child.

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is for external use only and must be used strictly as directed. It is important to stop use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using this product, patients should avoid contact with the eyes and should not apply it to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly. The product is flammable; therefore, it should be kept away from fire or flame.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. This product should be kept out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

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 Soothe (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

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. 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a healthcare 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 available information 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s condition.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's clinical status and initiate appropriate interventions based on the severity of the symptoms and the specific circumstances of the overdose. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health care professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical assistance immediately or contact a Poison Control Center for guidance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Care should be taken to keep the product away from fire or flame to prevent any hazardous situations. Additionally, it is crucial to keep the product out of reach of children to ensure safety.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center in the event of an overdose.

Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. They are also instructed to discontinue use and consult a doctor if their condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. While using the product, patients should avoid contact with the eyes, refrain from applying it to wounds or damaged skin, and should not bandage the area tightly.

Drug Information (PDF)

This file contains official product information for Soothe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)