Peach and Lily Peaches Slices Acne Clarifying Cleanser

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the treatment of acne. There are no teratogenic or nonteratogenic effects mentioned associated with its use.

Dosage and Administration

The affected area should be wetted prior to application. The product should be dispensed into the hands and gently massaged onto the face and neck, taking care to avoid the delicate eye area. A thin layer must be applied to cover the entire affected area, followed by thorough rinsing with warm water.

Initial treatment should begin with one application daily. Based on the patient's response and as directed by a healthcare professional, 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 daily or every other day.

Contraindications

Use of this product is contraindicated in individuals with a history of eye contact. In the event of contact with the eyes, it is imperative to flush thoroughly with water to mitigate potential irritation or injury. No other contraindications have been identified.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the application of this product may lead to skin irritation and dryness, particularly if used concurrently with other topical acne medications. In cases of irritation, it is recommended that patients limit their use to one topical acne medication at a time to minimize adverse effects.

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

This product may increase skin sensitivity to sunlight. Therefore, it is essential for patients to ensure adequate sunscreen protection while using this product and for at least one week following discontinuation of use to prevent sunburn or other phototoxic reactions.

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

Side Effects

Patients using this product should be aware that it is for external use only. The most common adverse reactions reported include skin irritation and dryness, particularly when used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised that patients use only one topical acne medication at a time.

In addition to skin irritation and dryness, patients may experience increased sensitivity to sunlight while using this product. It is crucial for patients to ensure adequate sunscreen protection during treatment and for at least one week following discontinuation of use.

Patients should also avoid contact with the eyes; in the event of contact, it is recommended to flush the eyes thoroughly with water. These precautions are important to mitigate potential adverse reactions associated with the use of this product.

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 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 Peach and Lily Peaches Slices Acne Clarifying Cleanser (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

For topical application, it is advised 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 as needed or directed by a healthcare professional. Should patients experience bothersome dryness or peeling, the frequency of application should be reduced to once daily or every other day.

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 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 teratogenic effects associated with its use. Therefore, pregnant women should avoid using products containing salicylic acid to mitigate any potential harm to fetal outcomes. Healthcare professionals are advised to counsel women of childbearing potential regarding these risks and to consider alternative treatments that are deemed safer during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may not need to take additional precautions when prescribing this medication to lactating mothers. However, it is always advisable to monitor breastfed infants for any potential effects, as individual responses may vary.

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 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 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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Healthcare providers should inform patients that the use of this product in conjunction with other topical acne medications may increase the likelihood of skin irritation and dryness. It is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

Patients must be cautioned to avoid contact with the eyes. In the event of accidental contact, they should flush the eyes thoroughly with water.

Additionally, it is important to communicate to patients that this product may increase skin sensitivity to sunlight. Therefore, they should ensure adequate sunscreen protection while using the product and for at least one week after discontinuation.

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, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommendation to cover the entire affected area with a thin layer and rinse thoroughly with warm water one to three times daily. To minimize the risk of excessive skin drying, patients should begin with one application daily and may gradually increase to two or three times daily as needed or as directed by a healthcare professional.

Clinicians should counsel patients that the product may increase skin sensitivity to sunlight. Therefore, it is essential for patients to ensure adequate sunscreen protection while using the product and for one week following its discontinuation.

Drug Information (PDF)

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

View product document (PDF)