Acne Biotic Moisturizer

Description

Active Clearing is a daily acne-targeting gel formulated to serve as an acne biotic moisturizer. The product is presented in a volume of 1.7 US fluid ounces (50 mL ℮) and is marketed under the Dermalogica brand.

Uses and Indications

This drug is indicated for the treatment of acne.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

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 can 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, 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 a day or every other day to alleviate these side effects.

Contraindications

Use is contraindicated in the following situations:

Contact with the eyes should be avoided; in the event of contact, the affected area must be flushed thoroughly with water. Additionally, if irritation or redness develops during use, the product should be discontinued immediately.

Warnings and Precautions

For external use only. It is imperative that this product is not applied in or near the eyes. In the event of contact with the eyes, it is essential to flush thoroughly with water to mitigate any potential irritation.

Should any irritation or redness develop during use, it is advised to discontinue application immediately. This precaution is crucial to prevent further adverse reactions.

This product must be kept out of reach of children to avoid accidental ingestion. In the case of swallowing the product, it is critical to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use in or near the eyes; in the event of contact, it is essential to flush the area thoroughly with water. If irritation or redness develops during use, patients are advised to discontinue application immediately.

When using this product, it is recommended to apply it solely to the affected areas. The likelihood of experiencing skin irritation and dryness may increase if another topical acne medication is used concurrently. Therefore, it is advised that only one topical acne medication be utilized at a time to minimize the risk of irritation.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

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 Acne Biotic Moisturizer (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 contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of Acne Biotic Moisturizer in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any concurrent medications of geriatric patients to ensure safe and effective use.

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, the prescribing information does not provide any dosage modifications for individuals who are pregnant. There are also no special precautions regarding 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 the use of this product in nursing 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 prescribing information 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 there is no available data to guide dosing or monitoring in this 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 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed about the importance of avoiding contact with the eyes. If contact occurs, they should flush the eyes thoroughly with water. Additionally, healthcare providers should counsel patients to discontinue use if any irritation or redness develops.

It is essential to instruct patients to apply the medication only to the affected areas. They should also be made aware that using this medication in conjunction with another topical acne treatment may increase the likelihood of skin irritation and dryness. Therefore, if irritation occurs, patients should limit their use to one topical acne medication at a time.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is intended for topical administration and is for external use only. Clinicians should advise patients to avoid contact with the eyes; in case of contact, patients should flush the area thoroughly with water. If irritation or redness develops, patients are instructed to discontinue use. It is recommended that the product be applied only to affected areas, as concurrent use with other topical acne medications may increase the likelihood of skin irritation and dryness. Patients should be reminded to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed.

Drug Information (PDF)

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

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