Peace Out Early Stage Acne Dot

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "B" on the other side. It contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and silicon dioxide.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with acne vulgaris, providing therapeutic benefits to manage and reduce the severity of this condition.

Dosage and Administration

Prior to application, the skin should be thoroughly cleansed. For products intended for topical use, the initial recommendation is to apply the product once daily. Based on individual response and as directed by a healthcare professional, the frequency may be gradually increased to two or three times per day.

In cases where bothersome dryness or peeling is experienced, it is advisable to reduce the application frequency to once daily or even every other day.

For new users, a sensitivity test is recommended. This involves applying the product sparingly to one or two small affected areas for the first three days. If no discomfort is noted during this period, the user may proceed with the previously mentioned application regimen.

Contraindications

There are no contraindications listed for this product. However, in the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. When utilizing this product, it is important to be aware that skin irritation and dryness may be exacerbated if another topical acne medication is used concurrently. In the event of irritation, it is recommended that only one medication be employed to mitigate adverse effects.

Healthcare professionals should advise patients to refrain from using this product if they have a known allergy to the dressing or any of its components, as this could lead to serious allergic reactions.

In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

While no specific instructions for discontinuation or general precautions are provided, it is essential for healthcare providers to monitor patients for any signs of adverse reactions and to counsel them on the appropriate use of this product to ensure safety and efficacy.

Side Effects

Patients using this medication may experience skin irritation and dryness, particularly if they concurrently use another topical acne medication. In such cases, it is advised that only one medication be utilized to minimize the risk of irritation.

Additionally, patients should be aware that this medication should not be used if they have a known allergy to the dressing or any of its components. It is essential for patients to disclose any allergies to their healthcare provider prior to starting treatment to avoid potential adverse reactions.

Drug Interactions

The concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to avoid the simultaneous application of multiple topical acne treatments. In cases where irritation occurs, it is recommended that only one medication be utilized to mitigate adverse effects. Monitoring for signs of skin irritation is essential to ensure patient comfort and treatment adherence.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

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

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to discuss the lack of data with patients who are pregnant or planning to become pregnant.

Lactation

There is no specific information regarding the use of Peace Out Early Stage Acne Dot in lactating mothers or lactation considerations. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers, as the effects on breastfed infants are not established. It is advisable to consider the potential risks and benefits before use in this population.

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 recommended dosing guidelines 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 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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

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 within a temperature range of 17ºC to 30ºC to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)