Herbal Healers Menthol Warming Roll on

Description

The product is presented in a roll-on dosage form, designed for topical application. It is packaged in a labeled container and box, identified as the HH Label and HH Box, respectively. The formulation is intended for warming pain relief, providing localized therapeutic effects.

Uses and Indications

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

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 exceeding 10 times per day, or as directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age. In such cases, consultation with a healthcare professional is advised prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Tight bandaging should be avoided to prevent compromised circulation.

• Contact with the eyes must be avoided to prevent irritation or injury.

• Application to wounds or damaged skin is contraindicated due to the risk of exacerbating the condition or causing further harm.

• Concurrent use with heating pads or other heating devices is not recommended, as it may lead to increased absorption and potential adverse effects.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

For external use only. Patients are advised to 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

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Herbal Healers Menthol Warming Roll on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Healthcare professionals should be consulted for appropriate alternatives or guidance. For adolescents aged 12 years and older, the recommended application is to the affected area no more than 10 times a day, or as directed by a healthcare provider.

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, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy, and the safety of its ingredients during this period has not been established. There are no specific contraindications listed for use during pregnancy; however, healthcare professionals are advised to consult with pregnant patients or those planning to become pregnant before use. No dosage modifications are provided for individuals who are pregnant. Given the lack of safety data, caution is recommended when considering the use of this product in pregnant women.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

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. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important to inform patients not to bandage the area tightly, as this may lead to complications.

Healthcare providers should also emphasize the importance of avoiding contact with the eyes and instruct patients not to apply the medication to wounds or damaged skin. Additionally, patients should be cautioned against using the medication in conjunction with heating pads or other heating devices, as this may increase the risk of adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. Freezing the product is strictly prohibited, as it may compromise its integrity. The container must be kept in an upright position to maintain its stability. Additionally, 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 no more than 10 times a day for adults and children aged 12 years and older, or as directed by a healthcare professional. For children under 12 years of age, the use of this medication is not advised without consulting a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Herbal Healers Menthol Warming Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)