Good Sense Hot and Cold Medicated Patch

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

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

Dosage and Administration

Adults and children over 12 years of age should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than 4 patches should be applied in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

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

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects. Additionally, contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. The application of this product to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and seek medical attention under the following circumstances: if the condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, patients should be instructed to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of worsening conditions, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to stop use and consult a healthcare professional. These warnings are crucial for ensuring patient safety and effective management of adverse reactions.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Hot and Cold Medicated Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should be evaluated by a physician prior to use. It is essential to consider the specific needs and conditions of this age group to ensure appropriate care and treatment.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed 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 the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data 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 use the medication only as directed. It is important to emphasize that patients should not bandage the area tightly or use the medication in conjunction with a heating pad, as this may lead to adverse effects.

Patients should be cautioned to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in pouches that must be resealed after opening to maintain integrity. It is essential to store the product at room temperature. Any unused portion should be discarded if not used after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children over 12 years. Patients should carefully remove the backing from the patch and apply the sticky side to the affected area, wearing one patch for up to 8 hours. This can be repeated as necessary, but no more than four times daily. For children aged 12 years or younger, consultation with a physician is advised.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging or use with heating pads. Contact with eyes and mucous membranes should be avoided, and the patch should not be applied to wounds or damaged skin. Pregnant or breastfeeding patients should seek advice from a health professional before use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Good Sense Hot and Cold Medicated Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)