Pacifica Clear Mist Facial Acne

Description

Pacifica Clear Mist Facial Acne Spray is a topical formulation designed for the management of acne. The product is presented in a spray dosage form, facilitating easy application to affected areas of the skin. The effective date for this formulation is April 25, 2024. The observation media for this product includes the label of the Pacifica Facial Acne Spray Clear Mist, which is available in image/jpeg format.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with acne vulgaris, providing therapeutic benefits to manage and reduce the severity of this condition.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The product should be applied as a thin layer to the entire affected area one to three times daily, depending on the patient's needs and the physician's recommendations.

For initial use, it is advised to start with one application per day. Based on the patient's response, the frequency may be gradually increased to two or three times daily. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once daily or every other day.

For new users, it is recommended to apply the product sparingly to one or two small affected areas during the first three days of treatment. If no discomfort is experienced, the patient may then proceed to follow the previously mentioned application guidelines.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it must be kept away from fire or flame. Users should avoid spraying the product near heat sources, sparks, or open flames to prevent any risk of ignition.

The contents of the can are under pressure. Users must not puncture or incinerate the can, as this could lead to hazardous situations. Additionally, the product should not be stored at temperatures exceeding 120°F to maintain its integrity and safety.

When utilizing this product, caution is advised regarding the concurrent use of other topical acne medications. The likelihood of skin irritation and dryness increases when multiple topical treatments are applied simultaneously. In the event of irritation, it is recommended to limit the use to one topical acne medication at a time.

In case of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. Users are advised not to spray the product near heat, sparks, sources of ignition, or flames. The contents of the can are under pressure, and it should not be punctured or incinerated. Additionally, it is crucial to store the product at temperatures not exceeding 120°F.

During the use of this product, skin irritation and dryness may occur, particularly if other topical acne medications are used concurrently. To minimize the risk of irritation, it is recommended that patients use only one topical acne medication at a time. If irritation does occur, patients should discontinue use and consult a healthcare professional.

Drug Interactions

The concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to limit the application to one topical acne medication at a time to mitigate the potential for irritation. If skin irritation occurs, the use of additional topical agents should be discontinued until the irritation resolves. Monitoring for signs of skin irritation is recommended when initiating or adjusting treatment regimens involving topical acne medications.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication 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 recommended.

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 this product during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risk to the fetus. Therefore, the use of topical salicylic acid during pregnancy should be avoided unless the potential benefits outweigh the risks. Healthcare professionals are advised to carefully consider the risk-to-benefit ratio when prescribing this product to pregnant patients.

Lactation

There are no specific warnings or precautions regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

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

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 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 based on clinical judgment.

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 patients closely for any signs or symptoms that may arise following 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 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 that if the medication is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in a pressurized container, which must be handled with care. It is essential to store the product at temperatures not exceeding 120°F. The container should be kept away from fire or flame, and it is crucial to avoid spraying near heat sources, sparks, or any ignition points. Due to the pressurized nature of the contents, the can must not be punctured or incinerated under any circumstances. Proper storage and handling are vital to ensure safety and maintain product integrity.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients that if irritation occurs, only one topical acne medication should be used at a time. In cases of bothersome dryness or peeling, patients are recommended to reduce the application frequency to once daily or every other day.

For new users, a sensitivity test is suggested: the product should be applied sparingly to one or two small affected areas during the first three days. If no discomfort is experienced, patients can proceed with the standard application instructions.

Drug Information (PDF)

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

View product document (PDF)