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. It is imperative that users refrain from bandaging the area tightly or applying heat via heating pads while using this product. Care should be taken to avoid contact with the eyes and mucous membranes, as such exposure may lead to adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent further complications.

Individuals with known allergies to any of the product's ingredients should not use it. In the event that the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, it is essential to discontinue use and consult a healthcare professional. Users should also seek medical advice if redness or irritation develops during the course of treatment.

To ensure safety, this product should be kept out of reach of children. In the case 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 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 strictly avoided, and the product should not be applied to wounds or damaged skin. Patients with known allergies to any of the ingredients in this product should refrain from use.

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 using the product and consult a healthcare professional. The presence of redness or the development of irritation also warrants discontinuation of use and seeking medical advice.

Additionally, if the product is ingested, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 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. For adolescents aged 12 years and older, the recommended dosage is to apply one patch to the affected area, with the option to repeat as necessary, not exceeding four applications in a 24-hour period.

It is essential 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 advised.

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.

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 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 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 lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; however, it is crucial to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention.

Management of overdosage should be guided by the severity of symptoms and the specific circumstances surrounding the incident. Healthcare providers are encouraged to follow established protocols for the treatment of overdosage, which may include supportive care and symptomatic treatment as necessary.

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.

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 any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or irritation develops.

When using this product, patients must be reminded to use it only as directed. They should be cautioned against bandaging tightly or using the product in conjunction with a heating pad. It is important to avoid contact with the eyes and mucous membranes, and patients should not apply the product to wounds or damaged skin. Additionally, patients should be informed not to use the product if they are allergic to any of its ingredients.

Storage and Handling

The product is supplied in a resealable pouch. It is essential to reseal the pouch after each use to maintain the integrity of the contents.

Storage conditions require the product to be kept 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 adhere to general guidelines for similar products. Special handling needs include ensuring that the pouch is securely resealed after each opening to prevent contamination and degradation of the product.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, one patch should be applied to the affected area, with the option to repeat this application as necessary, not exceeding four times 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)