Soothing Pain Relief

Description

Rejuvenetics™ is a roll-on formulation designed for soothing pain relief. The product is presented in a dosage form of 2 fluid ounces (59.1 mL).

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with the eyes should be avoided due to the potential for irritation or damage. Application to wounds or damaged skin is contraindicated to prevent adverse reactions and ensure proper healing. Additionally, tight bandaging of the area where the product is applied is not recommended, as it may lead to complications or hinder the effectiveness of the treatment.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued immediately, and a physician should be consulted.

This product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, it is advised not to bandage the area tightly after application, as this may hinder proper healing and increase the risk of adverse effects.

To ensure safety, this product must be kept out of reach of children. In the case of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes, as this may lead to irritation or other adverse effects.

In clinical practice, patients are advised to discontinue use if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. In such cases, consultation with a physician is recommended.

While using this product, patients should refrain from applying it to wounds or damaged skin, and should avoid tightly bandaging the area of application.

Additionally, 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 a Poison Control Center is advised.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the medication. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Soothing Pain Relief (menthol, unspecified form). 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, 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, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients provided in the drug insert. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

The available data regarding the use of this product during pregnancy is limited, as no specific information is provided in the drug insert. 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 use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this product.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

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

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be cautioned to avoid contact with the eyes. If the product inadvertently comes into contact with the eyes, they should rinse thoroughly with water and seek medical attention if irritation persists.

It is important for patients to monitor their condition closely. They should be instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Patients should also be informed not to apply the product to wounds or damaged skin, as this may lead to adverse effects. Additionally, they should be advised against tightly bandaging the area where the product is applied to ensure proper healing and to avoid complications.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a physician is advised 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 Soothing Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)