Prohemp Soothing Menthol Rub 4%

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older. It should be applied as needed, with a maximum frequency of four times daily. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

Adults and children aged 12 years and older should apply the medication to the affected area as needed, with a maximum frequency of four times daily. For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid contact with the eyes or mucous membranes. Application to wounds, damaged skin, or areas of very sensitive skin is contraindicated. Additionally, users should refrain from tightly bandaging the area or using a heating pad in conjunction with this product.

In the event of excessive redness or irritation, or if the condition worsens, it is essential to discontinue use and consult a healthcare professional. Users should also seek medical advice if pain persists for more than 7 days or if symptoms resolve only to recur within a few days.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use. This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product strictly as directed and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or very sensitive areas. Additionally, patients should refrain from bandaging tightly or using the product in conjunction with a heating pad.

In the event of excessive redness or irritation, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. If pain persists for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should also be sought. Pregnant or breastfeeding individuals should consult a health professional prior to use.

It is crucial to keep this product out of the reach of children. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Prohemp Soothing Menthol Rub 4% (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 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 advised.

For dosing, adults and children aged 12 years and older may apply the medication to the affected area as needed, not exceeding four times daily. For children under 12 years of age, it is recommended to consult a doctor before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, 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 breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 specific information 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 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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health 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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from direct sunlight and moisture. The product must not be frozen, as this may compromise its integrity.

To maintain safety, the product should be kept out of reach of children. Additionally, once opened, the product should be discarded to prevent any potential contamination or degradation. Proper handling and storage are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children aged 12 years and older being up to four times daily on the affected area as needed. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only. Patients are instructed to use the product as directed, avoiding contact with eyes and mucous membranes, and not to apply it to wounds, damaged, or very sensitive skin. It is important to avoid tight bandaging or the use of heating pads with the product. Patients should discontinue use and consult a doctor if excessive redness or irritation occurs, if the condition worsens, if pain persists for more than seven days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use. The product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Prohemp Soothing Menthol Rub 4%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)