Broda Acne

Description

BRODA Acne Spot Treatment is formulated with Anti-acne IntelliGel™ technology, designed to deliver maximum strength acne medication with 2% beta hydroxyl acid. This treatment is suitable for sensitive skin and is presented in an alcohol-free hydrogel dosage form. The product forms a TrueSkin invisible patch that adheres to the skin without causing peeling or flaking, ensuring that it does not dry the skin. Each treatment pen contains a net weight of 0.071 oz. (2g) or 0.71 oz. (20g). BRODA Acne Spot Treatment is manufactured and packaged in the USA and is distributed by Broda International, LLC, located at 10 Barley Court, Plainsboro, NJ 08536. The product is patent pending and can be found online at www.broda.com.

Uses and Indications

This drug is indicated for the treatment of acne and is designed to help prevent the formation of new acne blemishes. It utilizes a proprietary breakthrough technology, IntellGel™, which delivers maximum strength acne medication to effectively penetrate pores, thereby clearing most existing acne blemishes and assisting in the prevention of new acne pimples.

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

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer. This should be done one to three times daily, depending on the patient's needs and the physician's guidance.

To minimize the risk of excessive drying of the skin, it is advisable to initiate treatment with one application per day. Based on the patient's response and tolerance, the frequency may be gradually increased to two or three times daily as necessary or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once daily or every other day to alleviate these side effects.

Contraindications

Use is contraindicated in patients with a history of eye contact, as exposure may lead to irritation. In the event of contact with the eyes, it is essential to flush thoroughly with water to mitigate potential adverse effects.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

Skin irritation and dryness may be exacerbated when used concurrently with other topical acne medications. It is advisable to limit the use of topical acne treatments to one at a time to minimize the risk of irritation. Healthcare professionals should counsel patients to monitor for signs of skin irritation and dryness, and to discontinue use if these symptoms occur.

Care should be taken to avoid contact with the eyes. In the event of accidental contact, it is imperative to flush the eyes thoroughly with water to mitigate potential irritation.

In cases of ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay. Prompt action is essential to ensure patient safety.

Patients are advised to discontinue use and consult their healthcare provider if they experience any adverse effects or have concerns regarding their treatment.

Side Effects

Patients should be advised that the product is for external use only. This warning is critical to ensure safe and appropriate use, minimizing the risk of adverse reactions associated with improper application.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the stated warning. It is essential for healthcare providers to monitor patients for any unexpected reactions and to provide guidance on the correct use of the product to prevent potential complications.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of one of the medications is recommended to allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Broda Acne (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For topical application, it is recommended to initiate treatment with one application daily to minimize the risk of excessive skin drying. Dosage may be gradually increased to two or three times daily as needed or directed by a healthcare professional. If patients experience bothersome dryness or peeling, the frequency of application should be reduced to once a day or every other day.

Geriatric Use

There is no specific information regarding the use of BRODA ACNE - salicylic acid gel in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

The safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the risk of teratogenic effects associated with its use. Pregnant women should avoid using this product unless directed by a healthcare provider. It is essential for healthcare professionals to counsel women of childbearing potential regarding these risks and to consider alternative treatments when necessary.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 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 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that the use of this medication may lead to skin irritation and dryness, particularly if they are using another topical acne medication concurrently. It is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes. If contact occurs, patients should be advised to flush the eyes thoroughly with water to mitigate any potential irritation.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

To ensure safety, the product must be 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 advised. Special handling precautions should be observed to prevent misuse or accidental exposure.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)