Breakout Clearing Booster

Description

This product is supplied in a dosage form of 1.0 US fluid ounce (30 mL).

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

Healthcare professionals are advised to 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 direction.

To minimize the risk of excessive drying of the skin, it is recommended to initiate treatment with one application per day. Based on the patient's response, 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 advisable to reduce the frequency of application to once daily or every other day to alleviate these symptoms.

Contraindications

Use is contraindicated in patients with a history of eye contact, as the product should not be applied in or near the eyes. In the event of contact, it is essential to flush the affected area thoroughly with water.

Warnings and Precautions

For external use only. This product is contraindicated for use in or near the eyes. In the event of contact with the eyes, it is imperative to flush thoroughly with water to mitigate potential irritation.

When utilizing this product, it is essential to apply it solely to the affected areas. Concurrent use of another topical acne medication may increase the likelihood of skin irritation and dryness. Should irritation occur, it is recommended to limit the use to one topical acne medication at a time to minimize adverse effects.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for use in or near the eyes; in the event of contact, the affected area should be flushed thoroughly with water.

During the use of this product, participants may experience skin irritation and dryness, particularly if another topical acne medication is applied concurrently. To minimize the risk of irritation, it is advised that only one topical acne medication be used at a time.

Additionally, this product should be kept out of reach of children. In the case of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate these effects, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of one of the products 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 Breakout Clearing Booster (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 Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of Breakout Clearing Booster (salicylic acid liquid) in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor for any potential adverse effects and consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of treatment in this population. Additionally, since no dosage adjustments or specific safety considerations have been established for geriatric patients, careful clinical judgment is recommended.

Pregnancy

The product has not been evaluated for safety during pregnancy. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of salicylic acid during this period; therefore, it is essential for pregnant patients to consult a healthcare provider for advice. Additionally, dosage adjustments may be necessary for pregnant individuals, and medical guidance should be sought before use.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 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 not to use the medication in or near the eyes. If contact occurs, they should flush the area thoroughly with water to minimize irritation.

It is important to instruct patients to apply the medication only to the affected areas. They should be made aware that using this medication concurrently with another topical acne treatment may increase the likelihood of skin irritation and dryness. If patients experience irritation, they should be counseled to use only one topical acne medication at a time to avoid exacerbating the condition.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety.

For optimal storage conditions, it is recommended to keep the product in a cool, dry place, away from sources of heat and light. Proper handling practices should be observed to prevent any degradation of the product.

Additional Clinical Information

The route of administration for the medication is topical. Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients are instructed to seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)