Simply Vital Acne Face Cream

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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

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

To minimize the risk of excessive drying of the skin, it is advisable to initiate treatment with one application per day. Based on the patient's response and tolerance, 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 a day or every other day, as appropriate.

Contraindications

Use is contraindicated in the following situations:

In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised. Additionally, if irritation occurs, it is recommended to use only one topical acne medication at a time to prevent exacerbation of symptoms.

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 where irritation occurs, it is recommended that patients limit their use to one topical acne medication at a time to minimize adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Additionally, it is crucial for healthcare providers to counsel patients who are pregnant or breastfeeding to consult with a health professional prior to using this product, ensuring that any potential risks are adequately assessed.

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. It is advised that only one topical acne medication be utilized at a time to minimize the risk of irritation.

This product is intended for external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is advised prior to use to ensure safety for both the patient and the child.

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 Simply Vital Acne Face Cream (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.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Geriatric Use

There is no specific information regarding the use of SIMPLY VITAL Acne Face Cream 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 unique responses in this population. It is advisable to consider the overall health status and any comorbidities of geriatric patients when recommending this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Additionally, it is important to inform patients about the potential for skin irritation and dryness. They should be cautioned that using this medication concurrently with another topical acne treatment may increase the likelihood of these side effects. If patients experience irritation, they should be advised to limit their use to one topical acne medication at a time to minimize adverse effects.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer covering the entire affected area one to three times daily. Patients should begin with one application per day and may gradually increase 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 advised to reduce the frequency of application to once a day or every other day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)