Cold Hot Medicated Patch 5% Menthol

Description

Cold Hot Medicated Patch contains 5% menthol as its active ingredient. The specific physical characteristics and inactive ingredients are not detailed in the provided information.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for arthritis, simple backache, bursitis, tendonitis, cle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and older 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.

No more than one patch should be used within an 8-hour period. If necessary, the application may be repeated, but the total number of patches applied in a single day must not exceed three. 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:

• Application on infants is prohibited.

• The product should not be used if the condition worsens, if redness is present, or if irritation develops.

• Discontinue use if symptoms persist for more than 7 days or if symptoms clear up and recur within a few days.

• Avoid application in the presence of signs of injury, such as pain, swelling, or blistering at the site of application.

• Do not apply tightly bandaged or in conjunction with a heating pad.

• Contact with eyes and mucous membranes must be avoided.

• The product should not be applied to wounds or damaged skin.

• Concurrent use with other topical analgesics is contraindicated.

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.

Serious burns, although rare, have been reported with the use of similar products. To minimize the risk of adverse effects, it is imperative to avoid tight bandaging and the application of heating pads in conjunction with this product. Additionally, contact with the eyes and mucous membranes must be strictly avoided. The product should not be applied to wounds or damaged skin, nor should it be used concurrently with other topical analgesics.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Signs of injury, such as pain, swelling, or blistering at the application site, also warrant immediate consultation with a healthcare provider.

In cases of ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center without delay.

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, patients are 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, which may include pain, swelling, or blistering. In such cases, it is imperative 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 optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about overlapping therapies.

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 be treated with this medication if they are infants. For children under 12 years of age, it is recommended to consult a physician prior to use.

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 in these populations to ensure the safety of both the mother and the fetus or infant.

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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Rare cases of serious burns have been reported in postmarketing experience 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. They should report to their healthcare provider if their condition worsens, if redness is present, or if irritation develops. 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. Signs of injury, such as pain, swelling, or blistering at the application site, should also prompt immediate consultation with a healthcare professional.

It is essential to emphasize that patients must 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 avoid tightly bandaging the area where the product is applied and should not use it in conjunction with a heating pad.

Healthcare providers should instruct patients to avoid contact with eyes and mucous membranes and to refrain from applying the product to wounds or damaged skin. Furthermore, patients should be cautioned against using 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

The route of administration for the medication is topical. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. 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)