Cold Therapy

Uses and Indications

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

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

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

The product is contraindicated in the following situations:

• Application to open wounds or damaged skin is prohibited due to the risk of irritation and potential adverse effects.

• Contact with eyes and mucous membranes must be avoided to prevent serious irritation or injury.

• The use of bandages, heating pads, or devices in conjunction with the product is not recommended, as this may alter its effectiveness or lead to unwanted reactions.

• Concurrent use with other ointments, creams, sprays, or liniments is contraindicated to avoid potential interactions and reduce the risk of adverse effects.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended systemic exposure.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. This precaution is critical to ensure the safety and well-being of the patient.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then recur. Additionally, if redness or irritation develops, it is essential to stop using the product and seek medical advice.

Emergency medical help must be obtained in cases of accidental ingestion, reinforcing the importance of prompt action in such situations.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if the symptoms clear up and then recur, or if redness or irritation develops.

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 products may lead to altered absorption, increased risk of adverse effects, or diminished therapeutic efficacy. Therefore, it is advised to avoid concurrent use of these products.

There are no specific interactions identified with laboratory tests associated with this medication. Regular monitoring of patient response and any relevant clinical parameters is recommended, but no adjustments or specific precautions related to laboratory tests are necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication directly onto the affected area without the need for rubbing, massaging, or bandaging. The application may be repeated as necessary, but should not exceed four times daily.

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

In addition, the product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

There are no teratogenic or non-teratogenic effects reported in the nonclinical studies. Additionally, no information is available regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of accidental ingestion of the product. It is important to instruct patients to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Patients should also be informed to watch for signs of redness or irritation and to seek medical advice if these occur.

Patients must be reminded to use the product only as directed. They should be cautioned against bandaging the area or using heating pads or devices in conjunction with the product. Additionally, it is crucial to instruct patients to avoid contact with their eyes and mucous membranes, and to refrain from applying the product to open wounds or damaged skin.

Healthcare providers should emphasize that the product should not be used in combination with other ointments, creams, sprays, or liniments. After application, patients should be advised to wash their hands thoroughly with cool water to prevent unintended exposure.

Storage and Handling

The product is supplied in a secure container that must be stored in a cool, dry place. It is essential to ensure that the lid or cap is closed tightly to maintain the integrity of the product. Additionally, the product should be kept away from excessive heat and open flame to prevent any potential degradation or safety hazards.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)