Pain Relieving Patch

Description

No description information is available for the specified drug.

Uses and Indications

HuaShen Pain Relieving Patch is indicated for the continuous relief of pain for up to 48 hours. This patch is characterized by its fast, effective, and natural pain relief properties.

There are no teratogenic or nonteratogenic effects associated with the use of this product.

Dosage and Administration

For adults and children aged 2 years and older, the patch should be removed from its package and applied to the affected area. The application may be performed no more than 3 to 4 times daily. It is important to ensure that the bandage remains in place for no longer than 48 hours.

For children under 2 years of age, it is advised to consult a doctor prior to use.

Contraindications

Use is contraindicated in the following situations:

Pregnancy: The product should not be used during pregnancy due to potential risks to the developing fetus.

Skin Conditions: Use is contraindicated in individuals with a known skin allergy or any damage to the skin, as this may exacerbate adverse reactions.

Administration: The product should not be applied to the eyes or ears, as this may lead to serious complications.

It is essential to adhere strictly to the directions provided and avoid any use outside of the specified guidelines.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted.

General precautions must be observed when using this product. It should not be used otherwise than as directed, nor should it be applied in the eyes or ears. Additionally, individuals who are pregnant or have a skin allergy or damaged skin should refrain from using this product.

Healthcare professionals should advise patients to stop using the product and seek medical advice if any of the following occur: redness, excessive irritation of the skin, or any side effects. Side effects may be reported to the FDA at 1-800-FDA-1088.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with the eyes. In clinical practice, if the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, it is advised to discontinue use and consult a healthcare professional.

Participants should also stop use and seek medical advice if they experience redness, excessive irritation of the skin, or any side effects. Side effects may be reported to the FDA at 1-800-FDA-1088.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relieving Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the patch should be removed from the package and applied to the affected area no more than 3-4 times daily. The bandage should not be left on for more than 48 hours. It is important to keep this product out of reach of children to ensure safety.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in pregnant individuals remains unclear. Therefore, it is crucial for healthcare providers to advise women of childbearing potential to avoid this medication if they are pregnant or planning to become pregnant.

Lactation

Lactating mothers should not use this medication if they are pregnant. There is no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when considering the use of this medication in lactating mothers.

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

Nonclinical Toxicology

No relevant information was found regarding teratogenic or non-teratogenic effects. Additionally, there is no available data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that side effects may occur following the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088. Reports received are considered voluntary and contribute to ongoing surveillance of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to instruct patients not to use the product otherwise than as directed, and to avoid application in the eyes or ears. Patients should be informed that the medication is contraindicated for use during pregnancy and in individuals with a known skin allergy or damaged skin.

Providers should counsel patients to discontinue use and seek medical advice if they experience any redness, excessive irritation of the skin, or any side effects. Patients should be made aware that they can report side effects to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its integrity and effectiveness. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pain Relieving Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)