Menthol

Description

The 7FL OZ Pain Relief Cream is formulated for topical application. It is designed to provide localized relief from pain. The cream is presented in a 7 fluid ounce container, ensuring adequate volume for multiple applications. The formulation includes a blend of active and inactive ingredients, which work synergistically to alleviate discomfort. The product is characterized by its cream consistency, allowing for easy application and absorption into the skin.

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

Adults and children over 12 years of age are instructed to apply the product freely to the affected areas and to rub it in well. For the relief of colds, the product should be applied to the chest, back, and neck. In cases of head colds, it is recommended to apply the product 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 essential 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 any 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 patient seek medical advice.

Pregnant or breastfeeding individuals should also consult a healthcare professional before using this product to ensure safety for both the 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 application site is advised to identify any adverse reactions promptly.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should be applied as directed. Care should be taken to avoid contact with the eyes or other sensitive areas, as this may lead to irritation.

Individuals who have a history of allergic reactions to aspirin or salicylates are advised to consult their healthcare provider prior to use. If symptoms persist for more than seven days, it is recommended that patients seek medical advice. Additionally, pregnant or breastfeeding individuals should consult a health professional before using this product.

Patients should also be cautious not to bandage the area tightly or apply a heating pad, as these actions may exacerbate irritation. It is important to note that the product may cause irritation in individuals with sensitive skin.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol (owell naturals pain relief cream). 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 essential for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering individual patient factors and potential risks.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 implement supportive care measures, 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 intervention strategies.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 use of the compound in these contexts.

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 to emphasize the necessity of proper storage to ensure safety and minimize the risk of harm.

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 to prevent degradation. After opening, the product should be discarded to ensure safety and efficacy.

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)