Cvs Cold and Hot

Description

The product is identified by SPL code 34089-3 and is formulated as a topical spray. It contains active ingredients that deliver a cooling and soothing effect, intended exclusively for external use. The formulation includes inactive ingredients such as water, alcohol, and various botanical extracts. For ease of application, the product is packaged in an aerosol container.

Uses and Indications

This drug is indicated for the temporary alleviation of minor aches and pains associated with various conditions affecting muscles and joints. Specifically, it is effective for symptoms related to arthritis, simple backache, strains, bruises, and cramps.

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

Dosage and Administration

The product should be shaken well prior to use. For adults and children aged 12 years and older, the recommended administration is to spray the product on the affected area, with a maximum frequency of 3 to 4 times daily. For children under 12 years of age, it is advised to consult a healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application should not exceed one week to prevent potential adverse effects.

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

• The product should not be applied to wounds or areas of damaged, broken, or irritated skin due to the risk of exacerbating the condition.

• Bandaging or the application of local heat (including heating pads) or medicated patches to the treated area is contraindicated, as this may lead to increased absorption and potential toxicity.

• Exposure of the treated area to heat or direct sunlight should be avoided to minimize the risk of skin reactions.

• Application in skin folds is not recommended, as this may lead to irritation or other complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must not be used while smoking or near heat sources or flames. Long-term storage should be avoided at temperatures exceeding 104°F, and the product should not be punctured or incinerated. The contents are under pressure, and storage at temperatures above 120°F is prohibited.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users should read and follow all instructions and warnings on the label. Contact with eyes and mucous membranes must be avoided. There have been rare reports of serious burns associated with similar products. Consequently, this product should not be applied to wounds or to damaged, broken, or irritated skin. Bandaging or applying local heat, such as heating pads or medicated patches, to the area of application is contraindicated. A transient burning sensation may occur upon application, typically resolving within several days. However, if severe burning sensations arise, use should be discontinued immediately. The treated area should not be exposed to heat or direct sunlight, and application into skin folds should be avoided.

Users are advised to stop use and consult a healthcare professional if the condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days. The product should not be used for longer than one week.

In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flames. Long-term storage above 104°F should be avoided, and the product should not be punctured or incinerated, as it is under pressure. Additionally, it should not be stored at temperatures exceeding 120°F.

During use, it is critical to prevent contact with the eyes and mucous membranes. Rare cases of serious burns have been reported with similar products, highlighting the importance of applying the product only to intact skin. It should not be applied to wounds or damaged, broken, or irritated skin. Furthermore, patients should refrain from bandaging the area or applying local heat, such as heating pads or medicated patches, to the treated area.

A transient burning sensation may occur upon application, which typically resolves within several days. However, if patients experience severe burning sensations, they should discontinue use immediately. It is also advised to avoid exposing the treated area to heat or direct sunlight and to refrain from applying the product into skin folds.

Patients are instructed to stop use and consult a healthcare professional if the condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or clear up and recur within a few days. The product should not be used for longer than one week.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Cold and Hot (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents aged 12 years and older, the recommended dosage is to spray the product on the affected area no more than 3 to 4 times daily.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 of these patients.

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, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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 breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs. The nature of these reports does not imply a causal relationship, and further investigation may be warranted to understand the context of these occurrences.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. It is important to emphasize that the product should not be used for longer than one week.

When using the product, patients must be instructed to follow all directions and warnings on the label carefully. They should be cautioned against allowing the product to come into contact with their eyes and mucous membranes. Providers should inform patients that rare cases of serious burns have been reported with similar products, and therefore, the product should not be applied to wounds or damaged, broken, or irritated skin.

Patients should also be advised not to bandage the area of application or apply local heat, such as heating pads or medicated patches, to the treated area. A transient burning sensation may occur upon application, but this generally subsides within several days. If patients experience severe burning sensations, they should discontinue use immediately.

Additionally, patients should be cautioned not to expose the treated area to heat or direct sunlight and to avoid applying the product into skin folds.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to handle this product with care due to its flammable nature; therefore, it must not be used while smoking or in proximity to heat sources or open flames.

For optimal storage conditions, it is crucial to avoid long-term storage at temperatures exceeding 104°F. Additionally, the product should not be stored at temperatures above 120°F. It is important to note that the contents are under pressure; thus, puncturing or incinerating the container is strictly prohibited. Proper adherence to these guidelines will ensure the safety and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older should apply the topical spray to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is advised prior to use. Clinicians should counsel patients on the importance of avoiding use while smoking or near heat and flames, and to refrain from long-term storage above 104°F. The product is under pressure; therefore, it should not be punctured or incinerated, and should not be stored at temperatures exceeding 120°F.

Patients should be informed to avoid contact with eyes and mucous membranes, as rare cases of serious burns have been reported. The product should not be applied to wounds or damaged skin, nor should it be bandaged or subjected to local heat. A transient burning sensation may occur upon application, but if severe burning occurs, use should be discontinued immediately. Patients should avoid exposing the treated area to heat or direct sunlight and should not apply the product into skin folds. If symptoms worsen, redness or irritation develops, or if symptoms persist beyond 7 days or recur shortly after resolution, patients should seek medical advice. The product should not be used for longer than one week, kept out of reach of children, and if ingested, medical assistance should be sought immediately. Pregnant or breastfeeding patients should consult a healthcare professional before use.

Drug Information (PDF)

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

View product document (PDF)