Amazon Basics Cold and Hot Medicated Patch

Description

Amazon Basics Cold & Hot Medicated Patch is designed for therapeutic use, providing both cold and hot relief. The product is formulated to deliver effective pain management through its dual-action capabilities. The patch is intended for external application and is characterized by its adhesive backing, which ensures secure placement on the skin. The effective time of the patch is noted as January 1, 2023, indicating the date of its formulation or release.

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 aged 12 years and older 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 infants due to the potential for adverse effects.

Application should not occur on wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, contact with eyes and mucous membranes must be avoided to prevent serious irritation or injury.

Tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as it may increase the risk of skin irritation or other adverse reactions.

Concurrent use with other topical analgesics is also contraindicated, as this may lead to increased systemic absorption and heightened risk of side effects.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar products. It is imperative to avoid tight bandaging and the concurrent use of heating pads, as these practices may exacerbate the risk of adverse effects.

Contact with eyes and mucous membranes should be avoided to prevent irritation. Additionally, the product should not be applied to wounds or damaged skin, and it is contraindicated to use this product simultaneously with other topical analgesics.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

General precautions should be taken for individuals who are pregnant or breastfeeding; they are advised to consult a healthcare professional prior to using this product to ensure safety for both mother and child.

Side Effects

Patients using this product should be aware that it is for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of following usage instructions carefully. It is advised not to bandage tightly or use the product in conjunction with a heating pad. Additionally, contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Concurrent use with other topical analgesics is also not recommended.

Patients are instructed to stop use and consult a healthcare professional if their condition worsens, if redness or irritation develops, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, should prompt immediate medical consultation.

For pregnant or breastfeeding individuals, it is essential to seek advice from a healthcare professional before using this product. Furthermore, the product should be kept out of reach of children and should not be used on infants. In the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center (1-800-222-1222) is recommended.

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 signs of increased local irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical treatments.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this product if they are infants. For children under 12 years of age, it is advised to consult a physician prior to use.

For adolescents 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 should be discarded, and the pouch resealed to maintain integrity.

It is important to keep this product out of reach of children to prevent accidental exposure.

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data may necessitate individualized assessment and monitoring based on the patient's overall clinical status.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 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 their condition worsens, if redness occurs, if irritation develops, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

It is essential to emphasize that patients must use the product only as directed. Providers should inform patients that there have been rare reports of serious burns associated 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.

Healthcare 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 Amazon Basics Cold and Hot Medicated Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)