The Black Patch

Description

TBlkPtch is a transdermal patch formulation designed for the delivery of active pharmaceutical ingredients through the skin. The patch exhibits a specific molecular weight and is characterized by its unique chemical structure. It is composed of various inactive ingredients that facilitate the transdermal delivery mechanism. The dosage form is intended for application to intact skin, providing a controlled release of the active component over an extended period. The appearance of TBlkPtch is consistent with standard transdermal patches, ensuring ease of use and effective adherence to the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is free from any other topical products prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and refrain from applying the product to wounds or damaged skin. Additionally, it is important to instruct patients not to bandage the area tightly after application.

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, patients should be advised to discontinue use and consult a healthcare provider.

Emergency medical assistance should be sought immediately if the product is ingested. Patients should be instructed to contact a Poison Control Center or seek medical help without delay.

It is crucial for healthcare professionals to monitor patients for any adverse reactions or worsening of their condition while using this product, ensuring that appropriate medical guidance is provided as necessary.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed, avoiding contact with the eyes. Additionally, it should not be applied to wounds or damaged skin, and patients should refrain from bandaging the area tightly.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Healthcare professionals should ensure that the product is kept 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 recommended.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There are no specific studies available regarding the effects of menthol on fetal development, and therefore, the potential risk to the fetus remains unclear. No specific dosage modifications are provided for pregnant individuals; however, it is advised to use the product only as directed and to avoid excessive use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, contacting a poison control center or consulting relevant clinical guidelines may provide additional insights into the management of overdose situations.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients, particularly in households with children.

Storage and Handling

The product is supplied in a hydrogel formulation designed for optimal skin contact. It is essential to store the hydrogel at room temperature to maintain its efficacy. Prior to application, the skin should be thoroughly cleaned of any oil, dirt, or lotions and dried completely to ensure proper adhesion.

For enhanced stability and effectiveness, it may be beneficial to secure the patch in place using medical tape around the edges or a tension bandage. In the event that hydrogel residue transfers onto the skin or clothing, it can be easily removed with warm water or during laundry.

To ensure safety, the product should be kept out of reach of small children.

Additional Clinical Information

The hydrogel is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, consultation with a doctor is advised. For optimal results, the hydrogel should be applied to clean, dry skin, free from oil, dirt, and lotions. Clinicians may suggest using medical tape or a tension bandage to secure the patch in place.

While the Black Patch is designed for easy application and residue-free removal, some hydrogel residue may transfer due to heat or moisture. In such cases, the residue can be washed off with warm water or through laundering. It is important to note that the Black Patch is made in America with natural, food-grade ingredients, but it is not edible and should be kept out of reach of small children.

Drug Information (PDF)

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

View product document (PDF)