Good Neighbor Pharmacy Cold Therapy Pain Relief Patch

Description

The Good Neighbor Pharmacy Cold Therapy Pain Relief Patch is designed for localized pain relief. This product is effective as of April 1, 2023. The patch utilizes cold therapy to alleviate discomfort associated with various conditions. Its formulation is intended for topical application, providing a convenient and targeted approach to pain management.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for 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 three patches in a 24-hour period. After use, the patch must be discarded, and the pouch should be resealed to maintain product integrity.

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 is not recommended for infants due to potential safety concerns.

• Avoid tight bandaging or the use of heating pads in conjunction with the product, as this may lead to adverse effects.

• Contact with eyes and mucous membranes should be strictly avoided to prevent irritation or injury.

• The product should not be applied to wounds or damaged skin to reduce the risk of complications.

• Concurrent use with other topical analgesics is contraindicated to prevent potential interactions and enhance safety.

Warnings and Precautions

For external use only. This product is contraindicated for use on infants. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness develops, irritation is experienced, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should seek medical attention if they notice signs of skin injury, including pain, swelling, or blistering at the site of application.

In cases of ingestion, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, individuals should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern for inadvertent overlap in therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pharmacy Cold Therapy Pain Relief Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product without consulting a physician. The product is not indicated for infants. For children aged 12 years and older, the application involves carefully removing the backing from the patch and applying the sticky side to the affected area. A single patch may be worn for up to 8 hours, with the possibility of repeating the application as necessary, but not exceeding three times daily. After use, the patch must be discarded, and the pouch should be resealed to maintain integrity.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

It is essential to emphasize that the product should be used only as directed. Healthcare providers should inform patients that rare cases of serious burns have been reported with similar products. Patients should be cautioned against tightly bandaging the area where the product is applied or using it in conjunction with a heating pad.

Providers should also instruct patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin. Furthermore, patients should be advised not to use this product simultaneously with other topical analgesics to prevent potential adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Good Neighbor Pharmacy Cold Therapy Pain Relief Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)