Dermaclear Bha Cleanser

Description

Manufactured for Dermaquest®, Inc., located in Hayward, California, this product is produced in the USA. The specific facility responsible for its production is identified as 1272 GK, NL.

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 cleanser should be emulsified with lukewarm water before application. Healthcare professionals are advised to instruct patients to gently massage the cleanser onto the skin, taking care to avoid the eye area. Following application, it is essential to rinse the skin thoroughly and pat it dry.

This product is not recommended for individuals with known allergies to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs).

Contraindications

Use of this product is contraindicated in patients with very sensitive skin due to the potential for adverse reactions.

Additionally, the product should not be used concurrently with other topical medications, as this may exacerbate skin dryness or irritation. If severe skin irritation occurs, discontinue use and consult a healthcare professional.

Contact with the eyes, lips, and mouth should be avoided to prevent irritation.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with very sensitive skin.

In the event of accidental ingestion, immediate medical assistance should be sought. Contact a Poison Control Center or seek emergency medical help without delay.

Patients are advised to discontinue use and consult a healthcare professional if severe skin irritation develops. Concurrent use with other topical medications is not recommended, and patients should inform their healthcare provider if they are using such products simultaneously.

Side Effects

Patients should be advised that the product is for external use only. In the event of severe skin irritation, it is recommended to discontinue use and consult a healthcare professional. Additionally, caution should be exercised when using other topical medications concurrently, as this may exacerbate adverse reactions.

Drug Interactions

Concurrent use of other topical acne medications may enhance the risk of skin dryness or irritation when used simultaneously or immediately after application of this product. In such cases, it is advisable to limit the use to one topical medication unless otherwise directed by a healthcare professional.

Additionally, this product is not recommended for individuals with known allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).

Packaging & NDC

Below are the non-prescription pack sizes of Dermaclear Bha 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 or contact with a Poison Control Center is essential.

This medication is not recommended for pediatric patients with known allergies to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). Caution should be exercised in this population to avoid potential adverse reactions.

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

Pregnant patients should exercise caution when using this product, particularly if they have very sensitive skin, as this may exacerbate skin reactions. The product is intended for external use only, and contact with the eyes, lips, and mouth should be avoided to prevent irritation.

In clinical practice, the concurrent use of other topical acne medications may lead to increased dryness or irritation of the skin; therefore, it is advisable that only one medication be used at a time unless otherwise directed by a healthcare professional. Pregnant patients should also be aware of the potential for increased sensitivity to the sun; in such cases, the application of a sunscreen is recommended to mitigate the risk of sunburn or skin damage.

Severe skin irritation may occur, and if this happens, it is important to discontinue use and consult a healthcare provider. Additionally, this product is not recommended for individuals with known allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs). Given these considerations, healthcare professionals should carefully evaluate the risks and benefits of this product for pregnant patients and those of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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

There is currently no information available regarding overdosage for this product. Healthcare professionals are advised to monitor patients closely for any adverse effects and to provide supportive care as necessary. In the absence of specific overdosage data, it is recommended that clinicians follow standard protocols for managing suspected drug overdoses, which may include symptomatic treatment and supportive measures. If an overdose is suspected, immediate consultation with a poison control center or a medical toxicologist is recommended for further guidance.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they have very sensitive skin. It is important to counsel patients to stop using the product and consult a doctor if they experience severe skin irritation or if they are using other topical medications concurrently.

When using this product, patients should be cautioned to avoid contact with the eyes, lips, and mouth. Additionally, they should be made aware that using other topical acne medications simultaneously or immediately after applying this product may lead to increased dryness or irritation of the skin. In such cases, patients should only use one medication unless directed otherwise by a healthcare professional.

Finally, patients should be advised to use sunscreen if they are sensitive to the sun or expect increased sun exposure while using this product.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to protect its efficacy. Additionally, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients to avoid contact with the eyes, lips, and mouth. Patients who are sensitive to sunlight or expect increased sun exposure should use a sunscreen. They are advised to discontinue use and consult a doctor if severe skin irritation occurs. Additionally, patients should be informed that using other topical acne medications concurrently or immediately after applying this product may lead to increased dryness or irritation of the skin; therefore, only one medication should be used unless directed otherwise by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Dermaclear Bha Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)