Healthwise Menthol Roll-on

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area. The area should be massaged gently until the product is thoroughly absorbed into the skin. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. In the event that the medication comes into contact with the hands, it is important to wash the hands with soap and water immediately.

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

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged, broken, or irritated skin is prohibited due to the potential for exacerbating the condition. Tight bandaging, local heat application (including heating pads), or the use of medicated patches on the treated area should be avoided to prevent adverse effects. Exposure of the treated area to heat or direct sunlight is contraindicated, as it may lead to increased irritation or other complications. Additionally, application into skin folds is not recommended due to the risk of trapping moisture and causing skin irritation.

Contact with eyes and mucous membranes must be avoided to prevent irritation or injury. If a severe burning sensation occurs during use, the product should be discontinued immediately.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to read and adhere to all instructions and warnings provided on the carton. It is imperative to avoid contact with the eyes and mucous membranes, as this may lead to adverse effects.

There have been rare reports of serious burns associated with products of this nature. Therefore, it is crucial to refrain from applying the product to wounds or any damaged, broken, or irritated skin. Additionally, patients should be cautioned against tightly bandaging the treated area or applying local heat, such as heating pads or medicated patches, as these practices may exacerbate the risk of injury.

Upon application, a transient burning sensation may occur; however, this typically resolves within several days. Should a severe burning sensation arise, patients must discontinue use immediately. Furthermore, it is essential to avoid exposing the treated area to heat or direct sunlight and to refrain from applying the product into skin folds.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

In the event of accidental ingestion, it is critical to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using this product should be aware that it is for external use only. There have been rare reports of serious burns associated with similar products, emphasizing the importance of adhering to safety guidelines. Users are advised to avoid contact with eyes and mucous membranes, and the product should not be applied to wounds or damaged, broken, or irritated skin. Additionally, it is crucial to avoid tight bandaging or the application of local heat, such as heating pads or medicated patches, to the area of use.

Upon application, a transient burning sensation may occur; however, this typically resolves within several days. If a severe burning sensation is experienced, patients should discontinue use immediately. It is also recommended to avoid exposing the treated area to heat or direct sunlight and to refrain from applying the product into skin folds.

Patients should stop using the product and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms clear up and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical attention.

Furthermore, the product is flammable and should be kept away from fire or flame.

Drug Interactions

No drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 medication 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 drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is swallowed, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs. The nature of these reports underscores the importance of ongoing monitoring and evaluation of product safety in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be aware of signs of skin injury, such as pain, swelling, or blistering at the application site, and should seek medical advice if these symptoms arise.

It is important to inform patients that the product is flammable and should be kept away from fire or flame. When using the product, patients should be reminded to use it only as directed and to read and follow all directions and warnings on the carton. They should avoid contact with eyes and mucous membranes, as rare cases of serious burns have been reported with similar products.

Patients should not apply the product to wounds or damaged, broken, or irritated skin. They should also be advised against tightly bandaging the area or applying local heat, such as heating pads or medicated patches, to the treated area. A transient burning sensation may occur upon application, but this typically resolves within several days. If a severe burning sensation occurs, patients should discontinue use immediately. Furthermore, patients should avoid exposing the treated area to heat or direct sunlight and should refrain from applying the product into skin folds.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from fire or flame. Additionally, it is important to avoid exposing the area treated with the product to heat or direct sunlight to maintain its efficacy and safety.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the affected area for adults and children over 12 years. Patients should massage the product into the skin until fully absorbed, with a maximum frequency of 3 to 4 times daily. For children aged 12 years or younger, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)