Dr. Gross Ab Acne Daily Breakout

Description

Alpha Beta® Breakout Solution is a liquid formulation designed for the treatment of acne. The active ingredient, Salicylic Acid, is present at a concentration of 2% BHA. This product is packaged in a volume of 5.0 fl oz (150 ml ℮) and is indicated for the management of acne, including breakouts, clogged pores, and uneven skin tone and texture. The intended effects of the solution include exfoliation, clearing and prevention of acne, refinement of pores, evening of skin tone, and reduction of redness.

Uses and Indications

This drug is indicated for the treatment of acne. It penetrates the pores to eliminate most acne blemishes and blackheads. Additionally, it helps prevent the development of new acne blemishes and blackheads.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. To administer, a cotton ball should be placed over the pump, and the pump should be pressed firmly 2 to 3 times to saturate the cotton ball. The saturated cotton ball should then be used to cover the affected area once.

Initial treatment should consist of one application daily. Based on the patient's response and as directed by a physician, the frequency may be gradually increased to two or three times daily. In cases where bothersome dryness or peeling occurs, it is recommended to reduce the application frequency to once a day or every other day.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

• Contact with eyes should be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

The concurrent use of this product with other topical acne medications may increase the likelihood of skin irritation and dryness. In the event of irritation, it is recommended to limit the use to one topical acne medication at a time to mitigate 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 contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes, as this may lead to irritation.

Skin irritation and dryness are common adverse reactions that may occur, particularly if the product is used concurrently with another topical acne medication. In such cases, the likelihood of experiencing these reactions increases. If irritation does occur, it is recommended that patients limit their use to one topical acne medication at a time to mitigate these effects.

In the event that the product is swallowed, patients should 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 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 Dr. Gross Ab Acne Daily Breakout (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely to ensure the medication is kept out of reach, as ingestion may require immediate medical attention or contact with a Poison Control Center.

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 based on clinical need or physician guidance. In cases where bothersome dryness or peeling occurs, the frequency of application should be reduced to once daily or every other day to maintain skin integrity and comfort.

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 product has not been evaluated for use during pregnancy. Currently, there are no specific warnings or contraindications associated with the use of this product in pregnant patients. Additionally, no dosage modifications are recommended for individuals who are pregnant. Furthermore, there are no special precautions indicated for the use of this product during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action 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 and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

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

Patients should also be cautioned to avoid contact with their eyes, as this could lead to irritation or other adverse effects. Additionally, it is important to inform patients that using this medication concurrently with other topical acne treatments may increase the likelihood of skin irritation and dryness. If patients experience irritation, they should be advised to limit their use to one topical acne medication at a time to minimize the risk of adverse reactions.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, ensuring that it is protected from light exposure. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should inform patients that the formulation contains alpha hydroxy acid(s) (AHAs), which may heighten skin sensitivity to sunlight and increase the risk of sunburn. It is advisable for patients to use sunscreen daily, regardless of whether they are using this product, to mitigate the risks associated with sun exposure.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)