Oil-Free Foaming Acne Wash Facial Cleanser

Description

The product is a topical solution formulated with tea tree oil, specifically designed for the treatment of acne. It appears as a clear solution and possesses a characteristic tea tree scent. Inactive ingredients include water, glycerin, and propylene glycol. The SPL code for this product is 34089-3.

Uses and Indications

This XtraCare acne wash is indicated for the gentle cleansing of existing acne breakouts and for the prevention of future breakouts. It is formulated to penetrate deeply, providing a soothing effect without causing overdrying or irritation to the skin. The product rinses clean, ensuring that no residue remains to clog pores.

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

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; if contact occurs, the eyes must be flushed thoroughly with water.

Warnings and Precautions

This product is intended for external use only and may cause staining on certain fabrics. Healthcare professionals should advise patients to exercise caution to prevent fabric damage.

Concurrent use of this product with other topical acne medications may lead to increased dryness or irritation of the skin. In such cases, it is recommended that only one medication be used unless otherwise directed by a healthcare provider. Monitoring for signs of excessive dryness or irritation is advised.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Additionally, it is crucial to avoid contact with the eyes. Should contact occur, the affected area must be flushed thoroughly with water to mitigate potential irritation.

Side Effects

Patients should be aware that this product is for external use only and may cause staining on certain fabrics.

In clinical practice, when this product is used concurrently with other topical acne medications or immediately following its application, there is an increased risk of skin dryness or irritation. If patients experience such reactions, it is advised that they limit the use to one medication unless otherwise directed by a healthcare professional.

Drug Interactions

Concurrent use of this product with other topical acne medications may lead to an increased risk of skin dryness or irritation. In such cases, it is advisable to limit the use to one medication at a time unless otherwise directed by a healthcare professional. Monitoring for signs of excessive dryness or irritation is recommended to ensure patient comfort and skin health.

Packaging & NDC

Below are the non-prescription pack sizes of Oil-Free Foaming Acne Wash Facial Cleanser (salicylic 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 of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Care should be taken to avoid contact with the eyes; if contact occurs, the affected area should be flushed thoroughly with water.

When this product is used concurrently with other topical acne medications or immediately following its application, there is an increased risk of skin dryness or irritation. In such cases, it is advisable to use only one medication unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the risk of fetal harm associated with its use. Pregnant patients should avoid using products containing salicylic acid unless directed by a healthcare professional. Dosage modifications may be necessary for pregnant individuals, and it is advised to consult a healthcare provider before use.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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 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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available 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.

Additionally, it is important to inform patients to avoid contact with their eyes. Should contact occur, they should be directed to flush their eyes thoroughly with water to minimize any potential irritation or harm.

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 at a controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)