Quality Choice Cold Therapy Gel

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as arthritis, backache, strains, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected area, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion and potential complications. Additionally, the use of heating pads or devices in conjunction with this product is not advised due to the risk of increased irritation or adverse reactions. Contact with eyes or mucous membranes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin. During application, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is important for users to wash their hands with cool water after use and to avoid using the product with heating pads or devices.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. Prior to use, patients with sensitive skin are advised to consult a doctor.

While using this product, patients must avoid contact with the eyes or mucous membranes and should not apply it to wounds or damaged skin. It is also important to refrain from using the product in conjunction with other ointments, creams, sprays, or liniments, and to avoid application on irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and patients should wash their hands with cool water after use. Additionally, the product should not be used with a heating pad or device.

Patients are instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. For those who are pregnant or breastfeeding, it is advisable to seek guidance from a health professional before use.

This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or the Poison Control Center (1-800-222-1222) should be contacted.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The use of heat may enhance the absorption of the medication, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised to monitor for any signs of adverse reactions when using this medication, particularly in the context of its application with other topical agents or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to apply a thin film over the affected area up to 4 times daily. Massage of the area is not necessary.

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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as to consider any available data regarding fetal outcomes and maternal health. Healthcare providers should evaluate the necessity of treatment in the context of the patient's overall health and pregnancy status.

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 medication 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdose.

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 to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur.

When using this product, it is important to inform patients to avoid contact with their eyes or mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it in conjunction with other ointments, creams, sprays, or liniments. Patients should also be cautioned against applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and patients should wash their hands with cool water after use. Additionally, they should be advised not to use the product with a heating pad or any heating device.

Patients with sensitive skin should be encouraged to consult a doctor before using this product to ensure it is appropriate for their condition.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Healthcare professionals should ensure that the tube seal under the cap is intact before use; the product should not be used if this seal is broken.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)