Al00761 Alba Botanica Acnedote Face and Body Scrub

Description

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

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 is intended for use in cleansing the face, back, and other acne-prone areas. It may be applied every time the user washes or several times a week for a more thorough cleansing effect.

To administer, the user should scrub the affected areas gently to avoid irritation. Following application, it is essential to rinse the skin thoroughly to ensure complete removal of the product.

Contraindications

Use 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 Center is required.

• Discontinue use and consult a healthcare professional if irritation occurs.

Warnings and Precautions

The concurrent use of this product with other topical acne medications may lead to increased dryness or irritation of the skin. In such cases, it is advised that only one medication be utilized unless otherwise directed by a healthcare professional. Direct contact with the eyes should be avoided; in the event of contact, the eyes must be flushed thoroughly with water.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Center should be contacted without delay.

If any signs of irritation develop, the use of this product should be discontinued, and a healthcare provider should be consulted for further evaluation and guidance.

Side Effects

Patients using this product may experience adverse reactions, particularly when combined with other topical acne medications. The concurrent use of such products may lead to increased dryness or irritation of the skin. In the event of these symptoms, it is advised that only one medication be used unless directed otherwise by a healthcare professional.

Direct contact with the eyes should be avoided. Should contact occur, it is important to flush the eyes thoroughly with water to mitigate potential irritation.

In cases where irritation develops, patients are advised to discontinue use and consult a doctor for further guidance.

Drug Interactions

Concurrent use of other topical acne medications may lead to increased dryness or irritation of the skin when used simultaneously or immediately after the application of this product. In such cases, it is advisable to limit the use to one topical agent unless otherwise directed by a healthcare professional. Monitoring for signs of excessive dryness or irritation is recommended to ensure patient comfort and skin health.

Packaging & NDC

Below are the non-prescription pack sizes of Al00761 Alba Botanica Acnedote Face and Body Scrub (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 the Poison Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of Alba Botanica AcneDote Face and Body Scrub in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential sensitivities. Monitoring for any adverse effects is advisable when this product is used in the geriatric population.

Pregnancy

The safety of this product during pregnancy has not been established. The use of salicylic acid during pregnancy is generally contraindicated due to potential risks to the fetus, including the possibility of teratogenic effects. Pregnant women are advised to consult a healthcare provider before using this product. Special precautions should be taken to avoid the use of this product during pregnancy unless specifically directed by a healthcare professional.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any 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

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 is no information available regarding 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.

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 the patient closely for any potential symptoms that may arise from 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

The available nonclinical data does not indicate any teratogenic or non-teratogenic effects. Additionally, there is no information regarding animal pharmacology and toxicology. As such, no specific findings related to carcinogenesis, mutagenesis, or impairment of fertility have been identified in the conducted studies.

Postmarketing Experience

No postmarketing experience data has been reported.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event that the medication is swallowed, patients should seek medical help or contact a Poison Center immediately.

Additionally, patients should be instructed to discontinue use and consult a doctor if any irritation occurs. It is important for healthcare providers to ensure that patients understand these safety measures to promote proper use and minimize risks associated with the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product under controlled conditions to maintain its integrity and efficacy. The recommended storage temperature range is between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).

The product should be kept in its original container to protect it from light and moisture. Special handling precautions should be observed to prevent contamination and ensure the product remains within the specified temperature range during transport and storage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Al00761 Alba Botanica Acnedote Face and Body Scrub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)