Theracare Roll-on Menthol 16% Pain Relief Liquid

Description

No description information is available for the specified 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, 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 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. Additionally, tight bandaging, local heat application (such as 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 also contraindicated, as it may lead to increased irritation or other complications.

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 packaging. 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 the use of similar products. 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 intended for external use only. While the product is generally well-tolerated, rare cases of serious burns have been reported with similar products. 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 healthcare professional 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, patients should seek medical advice if they notice signs of skin injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Roll-on Menthol 16% Pain Relief Liquid (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 patients over 12 years, a thin layer of the product should be applied to the affected area and massaged into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or the Poison Control Center (1-800-222-1222) should be contacted.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

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 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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Upon application, a transient burning sensation may occur; however, this typically resolves within several days. In cases where a severe burning sensation is experienced, it is recommended to discontinue use immediately.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided in the context of animal pharmacology and toxicology.

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 is present, irritation develops, 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 cautioned against bandaging the area tightly 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 be advised 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 should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply a thin layer to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of 3 to 4 times daily. For children aged 12 years or younger, 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 crucial to keep the product out of reach of children; in the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

This file contains official product information for Theracare Roll-on Menthol 16% Pain Relief Liquid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)