H. E. B. Oil Free Daily Acne Scrub

Description

HEB20021A is identified by the SPL Code 34089-3. An image reference for HEB20021A is available for visual identification.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with this condition to help manage and reduce the severity of acne symptoms.

Dosage and Administration

The affected area should be covered with a thick layer of the product and rinsed thoroughly. Initial application should be limited to once daily 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 needed or as directed by a healthcare professional.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the application frequency to once daily or every other day. Careful monitoring of the skin's response is advised to ensure optimal results while minimizing adverse effects.

Contraindications

Use is contraindicated in patients with a history of eye contact, as exposure may lead to irritation. In the event of contact with the eyes, it is essential to flush thoroughly with water to mitigate potential adverse effects. No other contraindications have been identified.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek emergency medical assistance immediately if the product is ingested. In such cases, contacting a Poison Control Center is strongly recommended.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any adverse effects, although specific instructions for cessation are not provided.

It is important to note that the concurrent use of this product with other topical acne medications may increase the risk of skin irritation and dryness. Therefore, healthcare professionals should recommend that patients use only one topical acne treatment at a time to minimize the potential for irritation.

Additionally, care should be taken to avoid contact with the eyes. In the event of accidental contact, patients should be advised to flush the eyes thoroughly with water to mitigate any potential irritation.

No specific laboratory tests are recommended for monitoring the safe use of this product.

Side Effects

Patients should be aware that the product is intended for external use only. Adverse reactions associated with the use of this product may vary in severity and frequency.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

Healthcare professionals should monitor patients for any unexpected reactions and advise them to discontinue use and seek medical attention if they experience any severe or concerning symptoms.

Drug Interactions

The presence of an alpha-hydroxy acid (AHA) in this product may enhance the skin's sensitivity to ultraviolet (UV) radiation, thereby increasing the risk of sunburn. It is advised that patients utilize a broad-spectrum sunscreen, wear protective clothing, and limit sun exposure during the use of this product and for a duration of two weeks following discontinuation. This precaution is essential to mitigate the potential adverse effects associated with increased photosensitivity.

Packaging & NDC

Below are the non-prescription pack sizes of H. E. B. Oil Free Daily Acne Scrub (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

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. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for use during pregnancy. There are no specific warnings or contraindications mentioned regarding the use of this product in pregnant patients. Additionally, no dosage modifications are provided for individuals who are pregnant. The prescribing information does not indicate any special precautions regarding the use of this product during pregnancy. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants and the excretion of the drug in breast milk are not established.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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

Patients should be informed that using this medication in conjunction with other topical acne treatments may increase the likelihood of skin irritation and dryness. It is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes. If contact occurs, patients should be advised to flush the eyes thoroughly with water to mitigate any potential irritation.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It is important to note that the product may stain or damage certain fabrics, materials, or surfaces; therefore, care should be taken during handling and application.

For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and extreme temperatures. It is recommended to store the product in its original container to maintain its integrity and prevent contamination. Special handling precautions should be observed to avoid contact with sensitive materials that may be adversely affected.

Additional Clinical Information

The product is administered topically, with a recommended initial application of a thick layer to the entire affected area once daily. Clinicians may advise increasing the frequency to two or three times daily based on patient needs or specific directions. If patients experience bothersome dryness or peeling, they should reduce the application frequency to once daily or every other day.

Patients should be counseled to avoid contact with the eyes; in the event of contact, they should flush the area thoroughly with water. Additionally, due to the presence of an alpha-hydroxy acid (AHA) in the formulation, there is an increased sensitivity to sunlight, which may elevate the risk of sunburn. Therefore, it is essential for patients to use sunscreen, wear protective clothing, and limit sun exposure while using the product and for two weeks following discontinuation.

Drug Information (PDF)

This file contains official product information for H. E. B. Oil Free Daily Acne Scrub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)