Cvs Cold and Hot Roll-on

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor muscle and joint pain associated with conditions such as arthritis, simple backache, muscle strains, sprains, and bruises.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended application is to the affected area no more than 3 to 4 times daily. It is essential to ensure that the application is performed with clean hands and that the affected area is free from any other topical products prior to administration.

For children 12 years of age or younger, it is advised to consult a physician before use to determine the appropriate dosage and administration guidelines.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

When using this product, it is imperative to adhere strictly to the directions provided. Users should avoid bandaging the area tightly or applying heat through heating pads, as these practices may exacerbate adverse effects.

Contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. Additionally, the product should not be applied to wounds or any areas of damaged, broken, or irritated skin, as this may lead to further complications.

A temporary burning sensation may occur following application; however, this sensation typically resolves within several days. Should a severe burning sensation arise, it is crucial to discontinue use immediately. In the event of swelling or blistering of the skin, users should cease application and seek medical attention promptly.

Furthermore, it is essential to protect the treated area from heat and direct sunlight to minimize the risk of adverse reactions. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients may experience a temporary burning sensation following the use of the product; this sensation typically resolves within several days. In the event that a severe burning sensation occurs, it is advised to discontinue use immediately. Additionally, if patients notice swelling or blistering of the skin, they should stop using the product and seek medical attention promptly.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Cold and Hot Roll-on (cool and heat pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 12 years of age may apply the medication to the affected area no more than 3 to 4 times daily. For children 12 years or younger, it is advised to consult a doctor before use. Care should be taken to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare 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 addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. No additional non-teratogenic effects have been reported in the available data. There is no further information provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified a temporary burning sensation that may occur following the use of the product; this sensation typically resolves within several days. In cases where a severe burning sensation is experienced, it is advised to discontinue use immediately. Additionally, reports indicate that if swelling or blistering of the skin occurs, users should stop using the product and seek medical attention.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from direct sunlight and heat sources. To maintain safety, it is essential to keep the product out of reach of children. Special care should be taken to avoid exposing the treated area to heat or direct sunlight to ensure the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients on proper usage, emphasizing that the product should only be used as directed. It is important to avoid tight bandaging or the use of heating pads, and to prevent contact with eyes and mucous membranes. The medication should not be applied to wounds or damaged skin. Patients may experience a temporary burning sensation, which typically resolves within several days; however, if a severe burning sensation occurs, they should discontinue use immediately. In cases of swelling or blistering, medical attention should be sought. Patients should also be cautioned against exposing the treated area to heat or direct sunlight.

For children under 12 years of age, consultation with a healthcare provider is recommended prior to use. If the medication comes into contact with hands, it should be washed off with soap and water. Pregnant or breastfeeding patients should seek advice from a healthcare professional before using the product.

Drug Information (PDF)

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

View product document (PDF)