Perricone Md Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne T...

Description

No description information is available for the drug.

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 product should be shaken well before use. It is recommended to apply a thin, even layer to the skin in the morning. For optimal results, the application should follow cleansing with ACNE RELIEF Gentle & Soothing Cleanser. Prior to application, the skin must be cleaned thoroughly.

The product should be applied to the entire affected area with a thin layer one to three times daily. It is advisable to start with one application daily, gradually increasing to two or three times daily as needed or as directed by a healthcare professional. In cases where bothersome dryness or peeling occurs, the frequency of application should be reduced to once a day or every other day.

For new users, a sensitivity test is recommended. This involves applying the product sparingly to one or two small affected areas during the first three days. If no discomfort is experienced, the user may proceed with the full application instructions as stated.

Contraindications

Use of this product is contraindicated in patients who experience irritation. In such cases, it is advised to utilize only one topical acne medication at a time to prevent exacerbation of symptoms.

Warnings and Precautions

For external use only. It is imperative that this product is kept 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 strongly advised.

Side Effects

For external use only. No specific adverse reactions have been reported in clinical trials or postmarketing experiences. Patients should be advised to adhere strictly to the recommended usage guidelines to minimize the risk of adverse effects.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Perricone Md Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely when using this product. 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 application, it is recommended to start with one application daily to minimize the risk of excessive skin drying. If tolerated, the frequency may be gradually increased to two or three times daily, as directed by a healthcare professional. Should any bothersome dryness or peeling occur, the application frequency should be reduced to once a day or every other day.

For new users, a sensitivity test is advised. The product should be applied sparingly to one or two small affected areas for the first three days. If no discomfort is experienced, the patient may proceed with the full application instructions.

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.

Due to the lack of available data, it is advisable to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individualized assessment and consideration of the patient's overall health status, comorbidities, and concurrent medications are recommended to ensure safe and effective use in this population.

Pregnancy

Safety during pregnancy has not been established for this product. The use of this product is not recommended during pregnancy due to potential risks to the fetus. Specifically, there may be risks associated with the use of salicylic acid during this period.

Healthcare providers should be consulted for advice regarding dosage modifications and the appropriateness of use during pregnancy. It is essential for healthcare professionals to weigh the potential risks against the benefits when considering treatment options for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is critical. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered according to established protocols.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose. Continuous monitoring and supportive care are paramount until the patient stabilizes or further interventions are deemed necessary.

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 question.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, dryness, and allergic reactions. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

When discussing the use of 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. Therefore, healthcare providers should recommend that patients use only one topical acne medication at a time to minimize the risk of irritation. If patients experience any irritation, they should be instructed to discontinue use of the additional topical medication and consult with their healthcare provider for further guidance.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. 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 maintain its integrity. Additionally, the product must be kept out of reach of children, and any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommendation to apply a thin, even layer to the skin in the morning. Patients should cover the entire affected area with this layer one to three times daily, starting with one application per day and gradually increasing to two or three times daily as needed or directed by a clinician. In cases of bothersome dryness or peeling, patients are advised to reduce the frequency of application to once a day or every other day. New users should conduct a sensitivity test by applying the product sparingly to one or two small affected areas during the first three days of use.

Drug Information (PDF)

This file contains official product information for Perricone Md Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)