Menthol

Description

Cold Therapy Roll is a topical formulation designed for localized application. It is presented in a roll-on dosage form, facilitating ease of use. The product is intended to provide cold therapy for the relief of minor aches and pains.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before each use. For adults and children over the age of 2 years, a thin film should be applied to the affected area no more than 3 to 4 times daily. It is important to wash hands thoroughly with cool water after application to prevent unintentional contact with other areas of the body or with other individuals.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or use in conjunction with a heating pad or device, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

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

It is imperative to use this product only as directed. Healthcare professionals should advise patients to avoid contact with mucous membranes and to refrain from applying the product to wounds or damaged skin. Application to irritated skin should also be avoided, and if excessive irritation develops, use should be discontinued. Patients should not bandage the area tightly or use the product in conjunction with a heating pad or device, as this may exacerbate irritation or lead to adverse effects.

Special precautions should be taken when administering this product to children aged 2 years to under 12 years. It is recommended that use in this age group occurs only under adult supervision to ensure safety.

Patients should be instructed to stop use and contact their healthcare provider if they experience any of the following: pain, swelling, or blistering of the skin; worsening of their condition; or if symptoms persist for more than 7 days or resolve and then recur within a few days. Additionally, if arthritic pain persists for more than 10 days, or if redness is present, or if the patient is a child under 12 years of age, medical advice should be sought.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

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 excessive heat or open flame.

When using this product, patients should avoid contact with mucous membranes and should not apply it to wounds or damaged skin. It is also advised not to apply the product to irritated skin or if excessive irritation develops. Additionally, patients should refrain from tightly bandaging the area or using it in conjunction with a heating pad or device. For children aged 2 years to under 12 years, the product should only be used under adult supervision.

Patients are advised to stop use and consult a doctor if they experience pain, swelling, or blistering of the skin. If the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, medical advice should be sought. Furthermore, if arthritic pain persists for more than 10 days, or if redness is present, or if the product is being used in conditions affecting children under 12 years of age, patients should also seek medical attention.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Cold Therapy Roll on. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years to under 12 years should use this medication only under adult supervision. For both adults and children over 2 years of age, a thin film should be applied to the affected area no more than 3 to 4 times daily. In children under 2 years of age, it is advised to consult a doctor prior to use. Additionally, if any conditions affecting children under 12 years of age are present, the use of this medication should be discontinued, and a doctor should be consulted.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. Therefore, healthcare professionals should exercise caution when prescribing this drug to individuals with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual case. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be informed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For patients experiencing arthritic pain, it is important to advise them to stop use and consult a doctor if the pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age. Patients should be reminded to use the product only as directed and to avoid contact with mucous membranes.

Healthcare providers should caution patients against applying the product to wounds or damaged skin, as well as to irritated skin or if excessive irritation develops. It is also essential to inform patients not to bandage the area tightly or use the product in conjunction with a heating pad or device. For children aged 2 years to under 12 years, the product should only be used under adult supervision.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15ºC to 30ºC (59ºF to 86ºF) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent exposure to conditions outside the recommended temperature range.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin film over the affected area for adults and children over 2 years of age, not exceeding 3 to 4 times daily. It is advised that hands be washed with cool water after application. For children under 2 years, consultation with a healthcare provider is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)