Theracare Roll-on Menthol 4% Pain Relief

Description

No description information is available for the drug.

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, and bruises.

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 application should be followed by gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day. It is important to wash hands with soap and water immediately if the medication comes into contact with them.

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 and causing further irritation.

Tight bandaging or the application of local heat, including heating pads or medicated patches, to the area of use is contraindicated to prevent adverse effects.

Contact with eyes and mucous membranes must be avoided to prevent irritation and potential injury.

In the event of a severe burning sensation, use should be discontinued immediately to mitigate discomfort and prevent further complications.

Exposure of the treated area to heat or direct sunlight is contraindicated to avoid adverse reactions.

Application into skin folds is also discouraged to reduce the risk of irritation and other complications.

Warnings and Precautions

For external use only, this product carries specific warnings and precautions that must be adhered to in order to ensure safe application and minimize the risk of adverse effects.

Serious burns, although rare, have been reported with the use of similar products. Therefore, it is imperative that the product is not bandaged tightly, nor should local heat sources, such as heating pads or medicated patches, be applied to the area of use. Care should be taken to avoid contact with the eyes and mucous membranes, and the product must not be applied to wounds or any damaged, broken, or irritated skin.

Upon application, a transient burning sensation may occur; however, this typically resolves within several days. Should a severe burning sensation arise, the use of the product must be discontinued immediately. Additionally, the treated area should not be exposed to heat or direct sunlight, and caution should be exercised to avoid application into skin folds.

Healthcare professionals should advise patients to stop use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. Furthermore, if signs of skin injury such as pain, swelling, or blistering appear at the site of application, medical advice should be sought.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of careful application. Upon application, a transient burning sensation may occur; however, this sensation typically resolves within several days. If patients experience a severe burning sensation, they are advised to discontinue use immediately.

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

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Roll-on Menthol 4% Pain Relief (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 before use. For adolescents and children over 12 years, the recommended application involves applying a thin layer to the affected area and massaging it into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

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 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 specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 ingested, 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 compound in these areas.

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.

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 arises, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be made aware of the need to seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the application site.

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 be made aware that rare cases of serious burns have been reported with similar products.

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

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 at room temperature, ensuring that it is kept away from fire or flame. Additionally, the area treated with the product should not be exposed to heat or direct sunlight to maintain its efficacy.

In the event that the medicine comes into contact with hands, it is advised to wash the affected area thoroughly with soap and water. Proper handling and storage conditions are crucial to ensure the product's integrity and safety.

Additional Clinical Information

Patients aged 12 years and older should apply a thin layer of the product to the affected area, massaging it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children; in the event of ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Theracare Roll-on Menthol 4% Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)