Cold and Hot

Description

The product label is associated with an effective time of July 16, 2013. It is presented in a media type of image/jpeg. The reference value for this label is designated as hot-ncold-nat.jpg.

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

Adults and children over 1 year of age should apply the product generously to the affected area and massage it into the skin until it is thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times daily. For children aged 12 years or younger, it is advised to consult a physician prior to use. After each application, the cap should be closed tightly to ensure product integrity.

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

The product is intended for external use only and should be utilized strictly as directed. It is imperative to avoid applying the product to wounds or any damaged, broken, or irritated skin. Additionally, contact with the eyes and mucous membranes must be avoided to prevent adverse reactions.

When using the product, it is crucial not to bandage the area tightly or apply a heating pad, as this may exacerbate potential side effects. Furthermore, exposure of the treated area to heat or direct sunlight should be avoided to ensure safety and efficacy.

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

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use to ensure safety for both the mother and child. In the event of accidental ingestion, immediate medical assistance should be sought, or the poison control center should be contacted without delay.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and should be applied strictly as directed. Patients are advised not to bandage the area tightly or use a heating pad in conjunction with the product. Care should be taken to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Additionally, patients should refrain from exposing the treated area to heat or direct sunlight.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. If irritation develops, it is also recommended to stop use and seek medical advice. Pregnant or breastfeeding individuals should consult their healthcare provider before using this product.

In cases of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

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 over 1 year of age may apply the medication generously to the affected area, massaging it into the skin until thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times daily. For children 12 years of age or younger, it is advised to consult a doctor before use.

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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult with their healthcare professionals prior to using this medication. It is essential to evaluate the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making during pregnancy and lactation.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a configuration that requires careful handling to ensure its integrity and safety. It is essential to close the cap tightly after each use to maintain the product's efficacy and prevent contamination. Additionally, the product should be stored out of reach of children to ensure safety.

For optimal storage conditions, it is recommended to keep the product in a cool, dry place, away from direct sunlight and extreme temperatures. Adhering to these guidelines will help preserve the quality and effectiveness of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically, with instructions for adults and children over 1 year to apply generously to the affected area and massage until fully absorbed, not exceeding four applications daily. For children aged 12 years or younger, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only. Patients must follow directions carefully, avoiding tight bandaging or the use of heating pads, and should prevent contact with eyes and mucous membranes. It should not be applied to wounds or damaged skin, and treated areas should be shielded from heat and direct sunlight. Patients are advised to discontinue use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, or if irritation occurs. Pregnant or breastfeeding individuals should seek professional advice before use. In case of ingestion, immediate medical assistance or contact with a poison control center is necessary. The product should be kept out of reach of children.

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)