Acne Wash

Description

Face Values Oil-Free Pink Grapefruit Facial & Body Acne Wash is available in two dosage forms: a 9.1 fluid ounce (269 mL) bottle, with National Drug Code (NDC) 63940-053-54, and a 2 fluid ounce (59 mL) bottle, with NDC 63940-053-61. This product is formulated specifically for the treatment of acne on both the face and body.

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

The affected area should be covered with a thin layer of the medication and rinsed thoroughly. Initial application should be limited to once daily to minimize the risk of excessive skin drying. Based on the patient's response, the frequency may be gradually increased to two or three times daily, as needed or as directed by a healthcare professional.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the application frequency to once daily or every other day. Careful monitoring of the skin's response is advised to ensure optimal treatment outcomes while minimizing adverse effects.

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 or contact with a Poison Control Center is required.

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

Warnings and Precautions

For external use only. It is imperative that this product is not ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

General precautions must be observed to ensure safety. This product should be kept out of the reach of children to prevent accidental ingestion. In case of swallowing, prompt action is necessary to mitigate potential harm.

Healthcare professionals are advised to educate patients on the importance of these precautions to ensure safe usage and to emphasize the need for immediate medical intervention if the product is ingested.

Side Effects

For external use only. No specific side effects or adverse reactions have been reported in clinical trials or postmarketing experiences. Patients should be advised to use the product as directed and to consult a healthcare professional if any unexpected reactions occur.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. It is advised that only one topical acne medication be used at a time to minimize the potential for these adverse effects. If irritation does occur, discontinuation of one of the medications is recommended to alleviate symptoms. Monitoring for signs of skin irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For topical application, it is recommended to initiate treatment with one application daily. Depending on the patient's response and as directed by a healthcare professional, the frequency may be gradually increased to two or three times daily. Care should be taken to observe for excessive drying of the skin; if bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day.

Geriatric Use

There is no specific information regarding the use of Acne Wash (salicylic acid liquid) 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 for any potential adverse effects or interactions. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining the appropriateness of this treatment.

Pregnancy

Safety during pregnancy has not been established for the use of this product. The use of salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the possibility of teratogenic effects. Pregnant women should avoid the use of this product unless directed by a healthcare provider. It is essential for healthcare professionals to counsel women of childbearing potential regarding these risks and to consider alternative treatments when necessary.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 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, the following management procedures are recommended:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures based on the clinical presentation of the patient.

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 insert text.

Patient Counseling

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

When using this product, it is important to inform patients that skin irritation and dryness may be more likely to occur if they are using another topical acne medication concurrently. If patients experience irritation, they should be counseled to use only one topical acne medication at a time to minimize the risk of adverse effects.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. In the event of accidental contact, patients should be instructed to flush the eyes thoroughly with water to alleviate any potential discomfort.

Storage and Handling

The product is supplied in configurations that may include various packaging options. It is important to note that the product has the potential to stain certain fabrics, and appropriate precautions should be taken during handling to prevent any unintended damage.

For optimal storage, the product should be kept in a controlled environment, away from direct sunlight and extreme temperatures. Specific temperature ranges for storage have not been provided; however, it is advisable to maintain a stable environment to ensure product integrity.

Care should be taken to handle the product with clean, dry hands or appropriate gloves to minimize the risk of staining and to maintain the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)