Panitrol

Description

This product provides temporary relief from minor aches and pains associated with conditions such as arthritis, simple backache, sprains, bruises, and strains. It is formulated as a soothing and medicated analgesic rub specifically designed for application to aching joints and muscles. The product is effective for pre-exercise warm-up, delivering penetrating pain relief. Additionally, it includes skin moisturizing conditioners such as aloe, shea butter, avocado, and grape seed oil. The formulation features the clinically tested Panitrol herbal formula developed by Enzyme Labs, enhancing its efficacy in pain management.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including arthritis, simple backache, strains, bruises, and sprains. It serves as a soothing and medicated analgesic rub specifically designed for aching joints and muscles. Additionally, this formulation is effective for pre-exercise warm-up, providing penetrating pain relief.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician prior to use.

The product should be applied generously to the affected areas and massaged in until completely absorbed. It is advisable to apply the product before and after sports or exercise to help soothe aching muscles and alleviate muscle strain. Reapplication may be performed as needed, with a maximum frequency of four times per day.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and delayed healing. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to excessive heat and increase the risk of adverse effects.

Warnings and Precautions

For external use only. This product is not intended for internal use, and caution should be exercised to prevent accidental ingestion.

General precautions must be observed to ensure safe use. It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or a poison center should be contacted without delay. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may increase the risk of skin irritation or burns.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if excessive skin irritation develops. These precautions are essential to ensure the safety and well-being of patients using this product.

Side Effects

Patients should be aware that the product is intended for external use only. In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, excessive skin irritation may necessitate discontinuation of the product and seeking medical advice.

Before using the product, patients should consult a doctor if they have a history of allergic reactions to salicylates, including aspirin, or if they intend to use the product on a child under 12 years of age.

Drug Interactions

Patients should consult a healthcare professional prior to use if they have a history of allergic reactions to salicylates, including aspirin. This precaution is particularly important for individuals who may be sensitive to these compounds, as it could lead to adverse reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Panitrol (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before using this product. It is important for healthcare professionals to advise caregivers to seek medical guidance prior to administration in this age group to ensure safety and appropriateness of 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 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 lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison center immediately.

Patients should be informed not to use the product on wounds or damaged skin and to avoid using it in conjunction with a heating pad. It is important to counsel patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be advised to discontinue use and seek medical advice if they experience excessive skin irritation.

When using this product, patients must be instructed to follow the directions carefully and to avoid contact with the eyes or mucous membranes. They should also be cautioned against bandaging the area tightly after application.

Healthcare providers should recommend that patients consult a doctor before using the product if they have a history of allergic reactions to salicylates, including aspirin, or if they intend to use the product on a child under 12 years of age.

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 in a cool, dry place, ensuring it is kept away from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily, ensuring to massage it in until fully absorbed. For children under 12 years of age, consultation with a physician is recommended prior to use. The product may be applied before and after sports or exercise to alleviate muscle strain, with the option to repeat application as needed, up to four times per day.

Clinicians should counsel patients to avoid using the product on wounds or damaged skin and to refrain from using it in conjunction with a heating pad. Patients should be advised to seek medical advice if they have a history of allergic reactions to salicylates, including aspirin, or if they are considering use on a child under 12. It is important to use the product only as directed, avoiding contact with eyes or mucous membranes, and not to bandage tightly. Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist beyond 7 days, or if excessive skin irritation occurs. Pregnant or breastfeeding individuals should consult a healthcare professional before use, and the product should be kept out of reach of children, with immediate medical assistance sought if swallowed.

Drug Information (PDF)

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

View product document (PDF)