Topcare Maximum Strength Pain Relieving

Description

TopCare health® Cool n' Heat Roll-On Liquid is an external analgesic formulated with 16% menthol, designed for maximum strength relief. This product is available in a 2.5 fluid ounce (74 mL) container and is specifically designed to be stain-free. The formulation is comparable to Icy Hot® and is identified by NDC 36800-894-01.

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, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply the medication generously to the affected area. The application should be followed by a 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.

In the event that the medication comes into contact with the hands, it is advised to wash the hands thoroughly with soap and water.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

There are no specific contraindications identified for this product. However, the following precautions should be observed:

• Discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

• The product should not be applied to wounds or damaged skin to prevent potential irritation or adverse effects.

• Avoid tight bandaging of the area where the product is applied to ensure proper circulation and prevent skin irritation.

• The use of heating pads or other heating devices in conjunction with this product is not recommended, as it may increase the risk of skin irritation or burns.

Warnings and Precautions

For external use only, this product should be tested on a small patch of skin prior to generous application to ensure no adverse reactions occur. It is imperative that the product is used strictly as directed to minimize the risk of complications.

When utilizing this product, healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated, and it is important to avoid tight bandaging of the area treated. The use of heating pads or other heating devices in conjunction with this product is not recommended.

Patients may experience a transient burning sensation upon application; however, this typically resolves within several days. Should redness or skin irritation occur, it is advised to discontinue use immediately and consult a healthcare provider. Furthermore, if the condition worsens or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, patients should seek medical advice.

It is crucial 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 without delay.

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 it is recommended that a small patch of skin be tested prior to generous application to assess for any adverse reactions.

Common adverse reactions include skin irritation and a transient burning sensation upon application, which typically resolves within several days. If redness or irritation occurs, patients should discontinue use and consult a healthcare professional. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days, it is advised to stop use and seek medical advice.

Patients should also be informed that the product is flammable and should be kept away from fire or flame. Special precautions are advised for pregnant or breastfeeding individuals, who should consult a healthcare professional before use. Furthermore, this product should be kept out of reach of children; in the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Maximum Strength Pain Relieving (menthol, unspecified form). 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. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 maternal and fetal safety.

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 drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance 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 manage potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is imperative that healthcare professionals remain vigilant and follow established protocols for the treatment of overdosage to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. A transient burning sensation may occur upon application; however, this effect generally resolves within several days. No relevant information is available regarding nonclinical toxicology or animal pharmacology and 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 recur within a few days.

When using this product, patients must be instructed to use it only as directed. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. It is important to advise patients against bandaging the area tightly and to refrain from using heating pads or other heating devices in conjunction with the product.

Patients should be made aware that if redness is present, they should discontinue use and consult a doctor. Additionally, if skin irritation occurs, they should also stop using the product. A transient burning sensation may occur upon application; however, this sensation generally disappears within several days.

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 to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically, with patients advised to apply it generously to the affected area and massage it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

Clinicians should counsel patients that the product is for external use only and recommend testing a small patch of skin prior to generous application. Pregnant or breastfeeding patients should consult a healthcare professional before use. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance should be sought immediately or contact with a Poison Control Center (1-800-222-1222) should be made.

Drug Information (PDF)

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

View product document (PDF)