Menthol

Description

The product is available in multiple packaging options, including a 7 oz container with a pump, a 3.5 oz container with a pump, a 3.5 oz jar, and a 14 oz jar. Each packaging option is designed to facilitate ease of use and application.

Uses and Indications

This drug is indicated for the relief of arthritis pain, sore joints and muscles, sore throat, sinus trouble, and restless leg syndrome.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, the product should be applied freely to the affected areas and rubbed in well. For relief from colds, it is recommended to apply the product on the chest, back, and neck. In cases of head colds, the product should be applied around the nostrils, on the forehead, and behind the ears. Additionally, a small amount may be placed in a vaporizer to aid in symptom relief. For sore throats, the product should be applied liberally to the throat and neck.

For children 12 years of age or younger, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in situations where it may be accessible to children, as there is a risk of accidental ingestion or misuse. It is essential to ensure that the ointment is stored out of reach of children to prevent potential harm. No other specific contraindications have been identified.

Warnings and Precautions

For external use only; application should be conducted as directed. It is imperative to avoid contact with the eyes or other sensitive areas to prevent irritation or adverse reactions.

Individuals with a known history of allergic reactions to aspirin or salicylates are advised to consult a healthcare professional prior to use. In cases where symptoms persist beyond seven days, it is recommended that the individual seek medical advice.

Pregnant or breastfeeding individuals should also consult a healthcare professional before using this product to ensure safety for both mother and child.

Users should refrain from tightly bandaging the area of application or using a heating pad, as these practices may exacerbate irritation or lead to other complications. Additionally, caution is warranted as the product may irritate sensitive skin. Regular monitoring of the skin's response to the product is advised to mitigate potential adverse effects.

Side Effects

Patients may experience skin irritation, particularly those with sensitive skin. It is advised that individuals who have a history of allergic reactions to aspirin or salicylates consult their healthcare provider prior to use.

Drug Interactions

Patients with a known hypersensitivity to aspirin or salicylates should consult their healthcare provider prior to using this medication. This precaution is essential to avoid potential allergic reactions.

There are no specific drug or laboratory test interactions reported for this medication. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol (amish origins medicated). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult their physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, the following management procedures are recommended:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific interventions and treatments that may be appropriate based on the substance involved.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, even in the absence of specific overdosage information.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the ointment out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper use, particularly in young children. Providers should emphasize the necessity of storing the medication in a safe location, away from children's access, to ensure their safety.

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 to maintain its integrity. The container must be kept tightly closed to protect the contents from light exposure, which can compromise the product's efficacy. Additionally, it is important to discard the product after opening to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients who have a history of allergic reactions to aspirin or salicylates to consult their doctor prior to use. Patients are also encouraged to seek medical advice if their condition does not improve after seven days. Pregnant or breastfeeding individuals should consult a healthcare professional before using the product. Additionally, it is important to keep the ointment out of reach of children.

Drug Information (PDF)

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

View product document (PDF)