Cold and Hot Medicated Pain Relief Large

Description

Best Choice Cold and Hot Large Medicated Patch is a topical dosage form designed for the relief of pain. The patch is formulated to provide both cold and hot therapy, catering to various therapeutic needs. It is characterized by its large size, allowing for extensive coverage of affected areas. The patch is intended for external use and is designed to adhere securely to the skin, ensuring effective delivery of its active ingredients.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, muscle strains, simple backache, bursitis, cramps, tendonitis, muscle 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 dosage involves the careful removal of the backing from the patch. One patch should be applied to the affected area. This application may be repeated as necessary, but should not exceed four times daily.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the product should not be applied in the following situations:

• Do not bandage tightly or use in conjunction with a heating pad, as this may exacerbate adverse effects.

• Avoid contact with eyes and mucous membranes to prevent irritation.

• Do not apply to wounds or damaged skin, as this may lead to further complications.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients against tightly bandaging the area of application or using a heating pad concurrently, as these practices may exacerbate adverse effects.

It is imperative to avoid contact with the eyes and mucous membranes. Additionally, the product should not be applied to wounds or damaged skin to prevent further complications. Patients with known allergies to any of the product's ingredients should refrain from use.

In the event that the patient's condition worsens, symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days, it is essential to discontinue use and consult a healthcare provider. The presence of redness or the development of irritation also necessitates immediate medical advice.

In cases of accidental ingestion, prompt medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid bandaging tightly or using the product in conjunction with a heating pad. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Patients with known allergies to any of the ingredients should refrain from using this product.

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 are advised to stop use and consult a doctor. The presence of redness or the development of irritation also warrants discontinuation of use and medical consultation.

In cases where the product is ingested, immediate medical assistance should be sought, or the patient should contact a Poison Control Center.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 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 health professional 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be informed to stop using the product and seek medical advice if symptoms clear up and then recur within a few days, or if any redness or irritation develops.

It is essential for healthcare providers to emphasize that patients must use the product only as directed. Patients should be cautioned against bandaging tightly or using the product in conjunction with a heating pad. They should also be advised to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. Furthermore, patients should be informed that they should not use the product if they are allergic to any of its ingredients.

Storage and Handling

The product is supplied in a resealable pouch, which should be resealed after each use to maintain product integrity. It is essential to store the product in a cool, dry place, away from direct sunlight and moisture. Specific temperature ranges for storage have not been provided; therefore, it is advisable to keep the product at room temperature. Special handling requirements include ensuring that the pouch is securely closed after each opening to prevent contamination and degradation of the product.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children over 12 years, one patch should be applied to the affected area, with the option to repeat as necessary, not exceeding four applications daily. For children under 12 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)