Healthwise Medicated Cold Hot 5% Patch

Description

No specific description details are available for SPL code 34089-3 in the provided text.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various musculoskeletal 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 12 years of age and over should begin by cleaning and drying the affected area, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side of the patch applied directly to the affected area. It is important to note that no more than one patch should be used in an 8-hour period. The patch may be reapplied as necessary, with a maximum of three patches permitted per day. Each patch is for single use only and should be discarded after application. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

For children under 12 years of age, consultation with a physician is recommended prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Infants: The product should not be applied to infants due to safety concerns.

• Worsening condition: Discontinue use if the condition worsens.

• Redness: Do not use if redness is present.

• Irritation: If irritation develops, discontinue use.

• Persistent symptoms: If symptoms persist for more than 7 days or if they clear up and recur within a few days, do not continue use.

• Signs of injury: Discontinue use if there are signs of injury, such as pain, swelling, or blistering at the application site.

• Tight bandaging: Avoid tight bandaging or the use of a heating pad in conjunction with the product.

• Eye and mucous membrane contact: Avoid contact with eyes and mucous membranes.

• Wounds or damaged skin: Do not apply to wounds or damaged skin.

• Concurrent use with other topical analgesics: The product should not be used simultaneously with other topical analgesics.

Warnings and Precautions

For external use only. This product is not intended for use on infants. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens; if redness or irritation develops; if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days; or if any signs of injury occur, such as pain, swelling, or blistering at the application site.

In cases of ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event of worsening conditions, the presence of redness, or the development of irritation, it is advised to discontinue use and consult a healthcare professional. Additionally, if symptoms persist for more than 7 days, or if they resolve and then recur within a few days, medical advice should be sought.

Patients should also be vigilant for signs of injury at the application site, including pain, swelling, or blistering. If any of these symptoms occur, it is important to stop using the product and seek medical attention.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for any signs of increased irritation or adverse reactions is recommended if there is a need for analgesic therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise Medicated Cold Hot 5% Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a physician. The safety and efficacy of this product have not been established in infants, and its use is contraindicated in this population. Healthcare professionals are advised to consider these factors when prescribing to pediatric patients.

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 adverse effects or changes in therapeutic response, 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment and follow-up care.

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 use of the compound in these contexts.

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 not to use this product on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to monitor their condition closely. If symptoms worsen, if redness is observed, or if irritation develops, they should discontinue use and consult a healthcare professional. Additionally, patients should be instructed to seek medical advice if symptoms persist for more than 7 days or if symptoms clear up only to recur within a few days.

It is important to inform patients to watch for signs of injury, such as pain, swelling, or blistering at the site of application, and to report these symptoms to their healthcare provider. Patients should use the product only as directed and 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 using a heating pad in conjunction with the product. They should also avoid contact with eyes and mucous membranes, and not apply the product to wounds or damaged skin. Furthermore, patients should be advised not to use this product simultaneously with other topical analgesics to prevent potential adverse effects.

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 to ensure optimal performance. Each patch is intended for single use only and should be discarded after application.

Additional Clinical Information

Patients should apply the topical patch to a clean and dry affected area, ensuring it is free of lotions, ointments, and creams. For adults and children aged 12 years and older, only one patch may be used at a time for a maximum of 8 hours, with a total of up to three patches allowed per day. After use, the patch should be discarded, and the pouch resealed. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients on the proper use of the product, emphasizing that it should be used only as directed. Patients should be informed of the rare risk of serious burns associated with topical analgesics and advised against tight bandaging or the use of heating pads in conjunction with the patch. It is important to avoid contact with eyes and mucous membranes, and not to apply the patch to wounds or damaged skin. Patients should discontinue use and seek medical advice if their condition worsens, if redness or irritation occurs, if symptoms persist beyond 7 days, or if they experience signs of injury at the application site. Pregnant or breastfeeding patients should consult a healthcare professional before use.

Drug Information (PDF)

This file contains official product information for Healthwise Medicated Cold Hot 5% Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)