Acne Cleanser

Description

The product is a topical solution formulated with 2% salicylic acid. It appears as a clear, colorless to pale yellow liquid. Inactive ingredients include water, propylene glycol, sodium lauryl sulfate, among others. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the treatment of acne. It aids in the prevention of new acne blemishes from forming.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use. The application should begin on damp skin. A small amount of the product should be dispensed onto the fingertips and emulsified. The patient should then gently cleanse the skin using circular motions to ensure even distribution. After cleansing, the skin should be rinsed with warm water, and gently patted dry with a soft towel. Following this cleansing process, patients are encouraged to continue with their MONAT skincare routine for optimal results.

Contraindications

Use of this product 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 or contact with a poison control center is required.

• Contact with eyes should be avoided; if contact occurs, the eyes must be rinsed thoroughly with water.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the likelihood of skin irritation and dryness may increase if this product is used concurrently with other topical acne medications. In the event of irritation, it is recommended that only one topical acne treatment be utilized at a time to minimize adverse effects.

It is imperative to avoid contact with the eyes. Should contact occur, patients should be instructed to rinse their eyes thoroughly with water to mitigate potential irritation.

This product should be kept out of reach of children. In cases where the product is ingested, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. It is advised that only one topical acne treatment be utilized at a time to minimize the risk of irritation.

In addition, patients should avoid contact with the eyes; should contact occur, it is recommended to rinse the eyes thoroughly with water.

This product is intended for external use only. In the event of accidental ingestion, 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 treatment be utilized at a time. If irritation occurs, discontinuation of additional topical treatments is recommended to allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne medications.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is imperative to seek medical assistance or contact a poison control center immediately.

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 is not specifically contraindicated in pregnancy; however, caution is advised due to the active ingredient, salicylic acid. Salicylic acid is associated with potential risks during pregnancy, particularly when used in high doses or with systemic exposure. While no specific dosage modifications for pregnant individuals are provided, it is essential for healthcare providers to evaluate the risks and benefits of using this product in pregnant patients. It is recommended that women of childbearing potential consult a healthcare provider before use during pregnancy to ensure safety for both the mother and the developing fetus.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

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

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 intervention is crucial. If the product 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. It is recommended that individuals provide as much information as possible regarding the product ingested, including the quantity and time of ingestion, to facilitate appropriate medical response and management.

Healthcare providers should be prepared to monitor for any symptoms that may arise as a result of overdosage and implement necessary treatment protocols as guided by clinical judgment and established medical guidelines.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

When discussing the use of this product, healthcare providers should inform patients that skin irritation and dryness may be more likely to occur if they are using another topical acne medication concurrently. It is recommended that patients use only one topical acne treatment at a time to minimize the risk of irritation.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. In the event of accidental contact, patients should be instructed to rinse their eyes thoroughly with water.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The container should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients on the potential for skin irritation and dryness, particularly if another topical acne medication is used concurrently; it is advisable to use only one topical acne treatment at a time to minimize irritation. Patients should also be instructed to avoid contact with the eyes, and in the event of contact, to rinse the eyes thoroughly with water. Additionally, the product should be kept out of reach of children, and if ingested, medical assistance or contact with a poison control center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)