Topcare Pain Relieving Roll-on

Description

TopCare health® Pain Relieving Roll-On Gel is formulated with 4% menthol as its active ingredient, providing cold therapy for the relief of arthritis, back pain, and sore muscles and joints. The product is presented in a 2.5 fluid ounce (74 mL) container and features a no-mess applicator for ease of use. It is designed to have a vanishing scent and is paraben-free. This roll-on gel is comparable to Biofreeze® Roll-On. The National Drug Code (NDC) for this product is 36800-290-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is not necessary to massage the area after application.

For children under 2 years of age, it is advised to consult a doctor prior to use.

Contraindications

The product should not be applied to wounds or damaged skin. It is contraindicated for use in conjunction with other ointments, creams, sprays, or liniments, as this may lead to adverse effects. Application to irritated skin or in cases where excessive irritation develops is also contraindicated. Additionally, the product should not be bandaged tightly, nor should it be used with heating pads or heating devices, as these practices may exacerbate irritation or lead to other complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin.

When utilizing this product, it is imperative to avoid contact with the eyes. The application should not be made to wounds or damaged skin, and it is contraindicated to use this product in conjunction with other ointments, creams, sprays, or liniments. Additionally, it should not be applied to irritated skin or if excessive irritation develops. Patients should be instructed not to bandage the area tightly and to wash their hands thoroughly with cool water after application. The use of heating pads or heating devices in conjunction with this product is also discouraged.

Patients must be advised to discontinue use and seek medical consultation if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is flammable; therefore, it should be kept away from excessive heat or open flames. It is essential to keep this 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.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Additionally, patients are advised not to bandage the area tightly and to wash their hands with cool water after application. The use of heating pads or heating devices in conjunction with this product is also not recommended.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is important to note that the product is flammable; therefore, it should be kept away from excessive heat or open flames. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before using this product. Furthermore, the product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or other heating devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not necessary in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Pain Relieving Roll-on (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily, without the need for massage. For children under 2 years of age, consultation with a doctor is advised prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 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 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 medication. 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. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

When using this product, patients should be cautioned to avoid contact with the eyes and not to apply it to wounds or damaged skin. It is important to inform patients that they should not use this product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin or if excessive irritation develops. Patients should also be advised against bandaging the area tightly and should wash their hands with cool water after use. Additionally, they should not use this product with heating pads or heating devices.

Finally, healthcare providers should encourage patients to ask a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily, with no need for massage. For children under 2 years of age, consultation with a doctor is recommended prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)