Dch Labs Cool and Heat Roll-on

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc, iron oxide red, and iron oxide yellow.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 12 years and older, the product may be applied to the affected area up to 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Warnings and Precautions

For external use only; this product is flammable and should be kept away from fire or flame. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, it is important to instruct patients not to bandage the area tightly after application.

Patients should be closely monitored for any worsening of their condition. If symptoms persist for more than 7 days, or if they clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from fire or flame. When using this product, it is important to avoid contact with the eyes, and it should not be applied to wounds or damaged skin. Additionally, patients should refrain from bandaging the area tightly after application.

In the event that the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Dch Labs Cool and Heat Roll-on (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 healthcare professional 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 Labs Cool & Heat Roll-On during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 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 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, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidelines.

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 in the insert text.

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 classified as flammable; therefore, it must be kept away from fire or flame. It should be stored at room temperature to maintain its efficacy. Care should be taken to avoid contact with eyes, and it is important not to apply the product to wounds or damaged skin. Additionally, when using the product, do not bandage tightly to ensure proper application and safety.

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, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only and is flammable; it should be kept away from fire or flame. Patients are advised to avoid contact with eyes, not to apply it to wounds or damaged skin, and to refrain from tight bandaging. They should discontinue use and consult a doctor if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. It is also recommended to clean the affected area before application.

Drug Information (PDF)

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

View product document (PDF)