In the Clear Acne Serum

Description

HONEST® IN THE CLEAR ACNE SERUM is formulated with wintergreen-derived salicylic acid, niacinamide, and zinc PCA. This product is designed to address acne concerns effectively. It is presented in a dosage form of 1.0 fluid ounce (30 mL) and is manufactured in the USA using both domestic and imported materials. The serum is characterized by its clear appearance, aligning with its branding as "All Clear."

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 are advised to ensure that the skin is thoroughly cleaned prior to the application of this product. The affected area should be covered with a thin layer of the product, applied one to three times daily.

It is recommended to initiate treatment with one application per day, gradually increasing to two or three applications daily as necessary or as directed by a physician. In cases where bothersome dryness or peeling occurs, the frequency of application should be reduced to once daily or every other day to mitigate these effects.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

• Contact with eyes should be avoided; if contact occurs, the eyes must be rinsed thoroughly with water.

Warnings and Precautions

For external use only.

Skin irritation and dryness may be exacerbated when used concurrently with other topical acne medications. It is advised that only one topical acne treatment be utilized at a time to minimize the risk of irritation. Healthcare professionals should instruct patients to avoid contact with the eyes; in the event of contact, the affected area should be rinsed thoroughly with water.

In case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

No specific laboratory tests are recommended for monitoring during the use of this medication.

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.

In addition, patients should avoid contact with the eyes; should contact occur, it is recommended to rinse thoroughly with water.

This product is for external use only. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 In the Clear Acne Serum (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.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for In the Clear Acne Serum. As there is no available data regarding the use of this product in geriatric populations, healthcare providers should exercise caution when prescribing this serum to elderly patients. It is advisable to monitor these patients closely for any adverse effects or unexpected responses to treatment, given the lack of targeted clinical findings in this demographic.

Pregnancy

The product has not been specifically studied in pregnant patients, and no explicit warnings or precautions regarding its use during pregnancy are provided in the prescribing information. There are no stated safety concerns, contraindications, or dosage modifications for pregnant individuals. Additionally, no special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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 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 prescribing 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 may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

When using this product, 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 concurrently. Therefore, if irritation develops, patients should be instructed to use only one topical acne medication at a time to minimize the risk of adverse effects.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. Instruct patients that if contact occurs, they should rinse their eyes thoroughly with water to prevent irritation or injury.

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 in a dry and cool environment to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer to the entire affected area one to three times daily. Patients should begin with one application daily and may gradually increase to two or three times daily as needed or directed by a clinician. In cases of bothersome dryness or peeling, it is advised to reduce the frequency to once a day or every other day.

Clinicians should counsel patients that the product is for external use only and that skin irritation and dryness may be exacerbated by concurrent use of other topical acne medications. Patients should avoid contact with the eyes, rinsing thoroughly with water if contact occurs. Additionally, the medication should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

This file contains official product information for In the Clear Acne Serum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)