Cold and Hot

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to spray the affected area with the desired amount of the product. The formulation is designed to dry quickly on its own, eliminating the need for any rubbing or additional manipulation of the application site.

The product may be reapplied as necessary, with a maximum frequency of 3 to 4 times per day. It is important to adhere to this frequency to ensure optimal efficacy and safety.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid bandaging the area tightly or applying heat with a heating pad, as this may exacerbate adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation. The product must not be applied to wounds or any damaged, broken, or irritated skin, nor should it be sprayed on the face. Inhalation of the spray mist and fumes is also to be avoided.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, redness persists for more than 7 days, irritation develops, or symptoms continue for more than 7 days or resolve only to recur within a few days.

This product is flammable; therefore, it should not be used near heat sources, flames, or while smoking. Long-term storage should be avoided at temperatures exceeding 104°F (40°C), and the contents must not be punctured or incinerated under pressure. Additionally, storage at temperatures above 120°F (49°C) is contraindicated.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised.

Side Effects

Patients using this product should be aware that it is for external use only. It is essential to use the product only as directed and to avoid bandaging tightly or using a heating pad in conjunction with the application. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged, broken, or irritated skin. Additionally, patients should refrain from spraying the product on the face and should avoid inhaling the spray mist and fumes.

In the event that the condition worsens, redness persists for more than 7 days, irritation develops, or symptoms continue for more than 7 days or resolve and then recur within a few days, patients are advised to stop use and consult a healthcare professional.

The product is flammable; therefore, it should not be used near heat or flame or while smoking. Long-term storage above 104°F (40°C) should be avoided, and the product should not be punctured or incinerated, as it is under pressure. Storage at temperatures above 120°F (49°C) is also not recommended.

For pregnant or breastfeeding individuals, it is important to consult a healthcare professional before use. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is important to avoid using the product near heat or flame, or while smoking, to prevent potential hazards. In the event of accidental ingestion, immediate medical assistance should be sought, or the poison control center should be contacted without delay.

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, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their 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. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult healthcare professionals prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 event of an overdosage, immediate medical intervention is crucial. If the substance 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 substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate management strategy.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management of any complications arising from the overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

Storage and Handling

The product is supplied in a container that is designed to maintain the integrity of its contents. It is essential to store the product at temperatures below 104°F (40°C) and to avoid exposure to temperatures exceeding 120°F (49°C).

To ensure safety, the product must be kept out of reach of children. The container is under pressure; therefore, it should not be punctured or incinerated. Additionally, the product is flammable; it is crucial to refrain from using it near heat sources, flames, or while smoking. Proper handling and storage are vital to maintain the product's efficacy and safety.

Additional Clinical Information

The product is administered topically and may be repeated as necessary, but not more than 3-4 times daily. Clinicians should advise patients who are pregnant or breastfeeding to consult health professionals prior to use. In the event of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)