So Totally Clean Deep Pore Cleanser

Description

No specific description details related to SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for the treatment of acne, specifically to help clear existing acne blemishes and to prevent the formation of new acne lesions, including blackheads and whiteheads.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects noted.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended method of application involves moistening a cotton ball and applying a thin layer to the entire affected area. This can be done one to three times daily, depending on the patient's needs and the physician's guidance.

It is advisable to initiate treatment with one application per day 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 necessary. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once daily or every other day to alleviate these symptoms.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is required.

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

• Concurrent use with other topical acne medications is not recommended, as this may increase the likelihood of skin irritation and dryness. If irritation occurs, only one topical acne medication should be used at a time.

Warnings and Precautions

The product is intended for external use only. It is imperative to avoid contact with open flames or sources of ignition, as the product is flammable.

To ensure safety, the product must be 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 advised.

No specific laboratory tests have been identified for monitoring during the use of this product. However, healthcare professionals should remain vigilant regarding the general safety precautions outlined above to mitigate risks associated with its use.

Side Effects

Patients should be advised that the product is for external use only. It is important to note that the product is flammable; therefore, it must be kept away from open fire or flame to prevent any potential hazards.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

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 allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of So Totally Clean Deep Pore Cleanser (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 a poison control center should be contacted.

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 product has not been evaluated for safety during pregnancy. Currently, there are no specific statements regarding contraindications or risks to the fetus mentioned in the prescribing information. Additionally, no dosage modifications for pregnant individuals are provided. There are also no special precautions regarding the use of this product during pregnancy included in the insert. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or 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 event of an overdose, it is imperative to seek emergency medical attention immediately. Healthcare professionals should be aware that symptoms of overdose may manifest as severe drowsiness, confusion, and difficulty breathing.

Prompt recognition of these symptoms is crucial for effective management. Upon identification of an overdose, appropriate medical interventions should be initiated to ensure patient safety and mitigate potential complications.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a poison control center immediately.

Providers should also emphasize the importance of avoiding contact with the eyes. If contact occurs, patients should be instructed to flush the eyes thoroughly with water.

Additionally, 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 simultaneously. 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.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

Care should be taken to keep the product away from open fire or flame to prevent any potential hazards. Additionally, it is crucial to keep the product out of reach of children to ensure safety. Once opened, the product should be discarded to avoid any risks associated with prolonged exposure to air or contamination.

Additional Clinical Information

The medication is administered topically, with a recommendation to cover the entire affected area with a thin layer one to three times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for So Totally Clean Deep Pore Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)