Back and Large Extra Strength Cold-Hot Medicated Patches

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children 12 years of age and over should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. The application may be repeated as necessary, but should not exceed 4 patches in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches. Each patch is for single use only and must be discarded after removal.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

• Application should not involve tight bandaging or the use of heating pads, as this may lead to 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 damaged skin due to the risk of exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging the area tightly or using it in conjunction with a heating pad, as this may lead to adverse effects. Care should be taken to prevent contact with the eyes and mucous membranes, as exposure can result in irritation or injury. Additionally, the product must not be applied to wounds or damaged skin to avoid complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of the condition, the presence of redness, development of irritation, or if symptoms persist beyond 7 days or reappear shortly after resolution. These precautions are essential to ensure patient safety and to mitigate potential adverse reactions.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of worsening conditions, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to stop use and consult a healthcare professional. These warnings are crucial for ensuring patient safety and effective management of adverse reactions.

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 Back and Large Extra Strength Cold-Hot Medicated Patches (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be evaluated by a physician prior to use. It is essential to consider the specific needs and potential risks associated with this age group when determining treatment options.

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. The potential risks and benefits must be carefully considered, 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 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to dosing recommendations are crucial to minimize the risk of overdosage and ensure patient safety.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to emphasize that patients should not bandage the area tightly or use a heating pad in conjunction with the medication, as this may lead to adverse effects.

Patients should be informed to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in resealable pouches, which should be resealed after each opening to maintain integrity. Each patch is intended for single use only and must be discarded after use to ensure safety and efficacy. Proper handling of the product is essential to prevent contamination and ensure optimal performance.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children aged 12 years and older. Patients should carefully remove the backing from the patch and apply the sticky side to the affected area, wearing the patch for up to 8 hours. It may be repeated as necessary, but no more than four times daily. After use, the patch should be discarded, and the pouch resealed. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging or the use of heating pads, and to prevent contact with eyes and mucous membranes. The patch should not be applied to wounds or damaged skin. Patients are advised to discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist for more than 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a health professional before use.

Drug Information (PDF)

This file contains official product information for Back and Large Extra Strength Cold-Hot Medicated Patches, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)