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 provided in the text.

Contraindications

The product should not be used in the following situations:

• Bandaging or the use of heating pads or devices is contraindicated, as this may alter the product's effectiveness or safety profile.

• Contact with eyes and mucous membranes must be avoided to prevent irritation or adverse reactions.

• Application to open wounds or damaged skin is contraindicated due to the risk of exacerbating the condition or causing further injury.

• Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to unpredictable interactions or reduced efficacy.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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

Healthcare professionals should remain vigilant in monitoring patients for these signs and symptoms to ensure safe and effective use of the product.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur. Additionally, if redness is present or irritation develops, it is advised to stop use and seek medical advice.

Drug Interactions

Co-administration of this product with other topical formulations, such as ointments, creams, sprays, or liniments, is not recommended. The potential for altered efficacy or increased risk of adverse effects necessitates avoiding such combinations.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring related to laboratory tests are required.

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 under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the product may be applied directly onto the affected area without the need for rubbing, massaging, or bandaging. Applications can be repeated as necessary, but should not exceed 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

Pregnant patients should consult a health professional prior to using this medication. The potential risks and benefits must be carefully evaluated, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure appropriate management during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety of both the mother and the nursing infant.

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 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, even if they are not explicitly detailed in the available literature. Symptoms of overdose 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 standard supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies. Documentation of the incident and any interventions performed is crucial for ongoing patient care and for informing future treatment protocols.

Overall, while specific overdosage information is lacking, vigilance and adherence to established medical guidelines are paramount in managing potential overdose situations effectively.

Nonclinical Toxicology

Consultation with a health professional is advised prior to use due to potential teratogenic effects. No non-teratogenic effects have been reported in the available data. Additionally, there is no information provided regarding animal pharmacology and toxicology.

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 in the event of accidental ingestion of the product. It is important for patients to understand that they should discontinue use and consult their doctor 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, which may necessitate medical advice.

Patients must be instructed 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 avoid contact with the eyes and mucous membranes, as well as 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 reminded 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. Care should be taken to keep the product away from excessive heat and open flames 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)