Cold Hot Medicated Patch 5% Menthol

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 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 should be applied directly to the affected area.

It is important to note that no more than one patch should be used within an 8-hour period. Patches 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 is contraindicated in the following situations:

• Application is not recommended for infants due to potential safety concerns.

• Avoid tight bandaging or the use of heating pads in conjunction with the product, as this may lead to adverse effects.

• Contact with eyes and mucous membranes should be strictly avoided to prevent irritation or injury.

• The product should not be applied to wounds or damaged skin to reduce the risk of complications.

• Concurrent use with other topical analgesics is contraindicated to prevent potential interactions and enhance safety.

Warnings and Precautions

For external use only. This product is contraindicated 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; 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 site of application.

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

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, individuals should seek medical advice if they experience signs of injury, such as pain, swelling, or blistering at the site of application.

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 optimal therapeutic outcomes. Monitoring for signs of irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical treatments.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this product on infants. For children under 12 years of age, consultation with a physician is advised prior to use.

For adolescents aged 12 years and older, the application process involves 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 applied to the affected area. It is important to note that no more than one patch should be used in an 8-hour period, with a maximum of three patches allowed per day. After a single use, the patch must be discarded, and the pouch resealed after opening.

Healthcare professionals should ensure that this product is kept out of reach of children.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 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 discontinue use and consult a doctor if their condition worsens, if redness occurs, if irritation develops, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should seek medical attention if they experience signs of injury, such as pain, swelling, or blistering at the site of application.

It is essential to instruct patients to use the product only as directed. They should be made aware that rare cases of serious burns have been reported with similar products. Patients should also be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, and patients should be advised not to apply the product to wounds or damaged skin. Furthermore, patients should be informed that this product should not be used simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in a pouch that must be resealed after opening to maintain integrity. Each patch is intended for single use only and should be discarded after application. It is essential to store the product at room temperature to ensure optimal performance and safety.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children aged 12 years and older. Patients should clean and dry the affected area, ensuring it is free of lotions, ointments, and creams before applying the patch. The sticky side of the patch should be placed on the affected area, with a maximum of one patch used in an 8-hour period and no more than three patches applied in a single day. After use, the patch must be discarded, and the pouch resealed. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the product out of reach of children and to avoid use on infants. 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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)