Dch Cool and Heat

Description

The product is identified by SPL Code 34089-3 and is formulated as a topical spray. It contains active ingredients that elicit both cooling and heating sensations upon application. The formulation is complemented by a range of inactive ingredients that enhance the product's stability and overall effectiveness. For user convenience, the spray is packaged in an aerosol container, facilitating easy application.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with arthritis, simple backache, muscle strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The application should be performed with clean hands, ensuring that the area is dry before applying the medication.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only; this product is flammable and should be kept away from fire or flame. Users must avoid contact with the eyes. In the event of eye contact, it is imperative to flush the eyes thoroughly with water. The product should not be applied to wounds or damaged skin, and it should not be bandaged tightly. Additionally, it should not be used in conjunction with a heating pad. The contents are under pressure; therefore, users must not puncture or incinerate the container. Storage should not exceed temperatures of 120°F.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that this product is for external use only and is flammable; therefore, it should be kept away from fire or flame.

Common adverse reactions include irritation at the application site, which may manifest as redness, itching, or a burning sensation. Patients are advised to avoid contact with the eyes; in the event of contact, it is recommended to flush the eyes thoroughly with water.

Serious adverse reactions may occur if the product is applied to wounds or damaged skin, or if it is used in conjunction with a heating pad. Patients should not bandage the area tightly after application. Additionally, the product is under pressure, and patients should not puncture or incinerate the container. It is crucial to store the product at temperatures not exceeding 120°F.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Dch Cool and Heat (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of DCH Cool and Heat Spray, 16% Menthol during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential risks and benefits. It is advisable to consult relevant clinical guidelines and consider alternative therapies with established safety profiles during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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.

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 consider the potential risks associated with excessive administration of the medication.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdose. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and treatment planning. Continuous monitoring of the patient's vital signs and clinical status is also recommended until the patient is stabilized.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a container that is under pressure. It is essential to avoid storing the product at temperatures exceeding 120°F. Care should be taken to prevent puncturing or incinerating the container, as this may lead to hazardous situations. Proper handling and storage conditions are crucial to ensure the safety and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients that the product is for external use only and is flammable; therefore, it should be kept away from fire or flame. Patients should avoid contact with eyes, and in case of such contact, they should flush thoroughly with water. The product should not be applied to wounds or damaged skin, nor should it be tightly bandaged or used with a heating pad. It is important to note that the contents are under pressure, and the product should not be punctured or incinerated. Storage should not exceed 120°F. Patients are advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and recur within a few days. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Dch Cool and Heat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)