Qc Cool and Heat Roll-on

Description

The product, identified by SPL code 34089-3, is a topical analgesic formulated as a roll-on liquid. It contains menthol and camphor as active ingredients. The product is packaged in a 2.5 oz (74 mL) container. Inactive ingredients include water, propylene glycol, glycerin, alcohol, carbomer, triethanolamine, fragrance, and FD&C Blue No. 1 as a colorant.

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.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

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 the Poison Control Center should be contacted.

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 improve 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.

Healthcare professionals should ensure that patients are aware of these warnings and the importance of adhering to the recommended precautions for safe use.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame.

During use, patients should avoid contact with the eyes and refrain from applying the product to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application.

Patients are instructed 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. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Qc Cool and Heat Roll-on (menthol 16%). 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 adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of information related to pregnancy and advised to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

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 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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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.

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 patient safety and appropriate management of any potential risks associated with swallowing the medication.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety. Care should be taken to avoid contact with eyes, and the product must not be applied to wounds or damaged skin. Additionally, it is important to avoid bandaging tightly when using the product 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 Qc Cool and Heat Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)