Cold Hot Patch

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 aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort due to arthritis, simple backache, strains, sprains, bursitis, tendonitis, 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 may apply the patch to the affected area as needed, with a maximum frequency of four applications per day. For children under 12 years of age, it is advised to consult a physician prior to use.

For optimal application, healthcare professionals should instruct patients to grasp both ends of the pad firmly and pull at both ends to stretch the pad until the backing separates. The protective film should be removed while applying the pad directly to the site of pain.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to adhere strictly to the directions for use. It is imperative to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and patients should be cautioned against tightly bandaging the area or using a heating pad in conjunction with the product.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: excessive redness or irritation, worsening of the condition, persistent pain lasting more than 7 days, or if symptoms resolve and then recur within a few days.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional prior to using this product.

Additionally, 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 should be made without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is imperative to follow the directions provided and to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and it is advised not to bandage tightly or use a heating pad in conjunction with the application.

In the event of excessive redness or irritation, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. Additionally, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. This product should be kept out of reach of children, and in the case of accidental ingestion, immediate medical assistance or contact with a poison control center is necessary.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the patch may be applied to the affected area as needed, with a maximum frequency of four applications per day.

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 prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 on 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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 event of an overdosage, immediate medical assistance is crucial. If the substance is swallowed, it is imperative to seek medical help or contact a poison control center without delay.

To prevent accidental ingestion, it is essential to keep the product out of reach of children. This precautionary measure is vital in minimizing the risk of overdosage and ensuring the safety of pediatric populations.

Healthcare professionals should be prepared to provide supportive care and symptomatic treatment as necessary, depending on the specific circumstances of the overdosage incident.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to 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 medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a poison control center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, it should be kept out of reach of children to ensure safety. Once opened, the product must be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

Patients should be advised that the product is for external use only. Clinicians should instruct patients to apply the patch topically to the affected area as needed, with a maximum frequency of four times daily for adults and children aged 12 years and older. For children under 12 years, consultation with a doctor is recommended prior to use.

Patients must follow specific precautions: avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin, and refrain from tightly bandaging or using heating pads on the application site. They should discontinue use and consult a doctor if excessive redness or irritation occurs, if the condition worsens, if pain persists beyond seven days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use. The product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a poison control center is necessary.

Drug Information (PDF)

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

View product document (PDF)