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

Use of this product is contraindicated in the following situations:

• Bandaging or the use of heating pads or devices is not recommended, as this may alter the product's effectiveness or safety profile.

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

• Application to open wounds or damaged skin is contraindicated due to the risk of infection or further skin damage.

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

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur. Additionally, if redness or irritation develops, medical advice should be sought promptly.

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, 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

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 drug interactions.

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 use the product by spraying it 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.

It is important to keep the product 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. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication while 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

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. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

There were no teratogenic effects observed in the nonclinical studies conducted. Additionally, no non-teratogenic effects were reported. The available data does not include specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided 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 to inform patients that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur, they should consult their healthcare provider. Additionally, patients should be made aware that the presence of redness or the development of irritation warrants further evaluation.

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. It is essential to emphasize the importance of avoiding contact with the eyes and mucous membranes, as well as not applying the product to open wounds or damaged skin. Furthermore, patients should be informed that the product should not be used in combination with other ointments to prevent potential adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

Patients should spray the medication directly onto the affected area without rubbing, massaging, or bandaging. The application may be repeated as necessary, but it should not exceed four times daily. Clinicians are advised to counsel patients to consult a healthcare professional prior to use if they are pregnant or breastfeeding. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)