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Clearasil Ultra

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Clearasil Ultra

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Treatment option: Zits, Acne Vulgaris

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Clearasil Ultra

Property Description
Active Ingredient Benzoyl Peroxide (BPO)
Form Topical preparation (Cream, Gel, Lotion)
Pharmacological Class Anti-acne agent, Topical antimicrobial
Common Use Management of skin blemishes and Acne vulgaris
Origin Synthetic (Organic Peroxide)

Clearasil Ultra is a defined topical dermatological preparation primarily intended for localized application to the skin surface to manage blemishes. This brand is often positioned as a Rapid Action treatment, distinguishing it through its targeted approach relative to some other Over-the-counter (OTC) acne products. It is classified as an OTC monotherapy containing a single active ingredient, making it a readily accessible, non-prescription choice for individuals experiencing common skin concerns. The preparation is available in specialized pharmaceutical preparations, such as a cream, gel, or lotion, all designed for the effective topical delivery of the medication.

Active Composition and Pharmacological Class

The key active ingredient in this preparation is Benzoyl Peroxide (BPO), which is a synthetic organic peroxide compound. Pharmacologically, Benzoyl Peroxide is simultaneously classified as a robust anti-acne agent, a potent topical antimicrobial, and a keratolytic substance. This ingredient is categorized as generally recognized as safe and effective for use as an active ingredient in OTC topical acne drug products. This status confirms the active substance’s established role in helping to manage acne.

Primary Action and General Purpose

The general purpose of Clearasil Ultra is to target and manage the underlying processes that lead to the formation of acne lesions. This objective is achieved through the dual physiological actions of Benzoyl Peroxide. It functions as an oxidizing agent that releases oxygen into the skin’s follicles and possesses a desirable comedolytic effect. This mechanism assists in the reduction of Propionibacterium acnes (P. acnes)—the bacteria associated with acne inflammation—and its keratolytic properties aid in the gentle shedding of the outermost layer of dead skin cells. In essence, this compound provides a foundational treatment for Acne vulgaris by helping to clear existing lesions and potentially mitigating the development of new ones.

Regulatory References

  1. Benzoyl Peroxide - StatPearls - NCBI Bookshelf
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What side effects are possible with Clearasil Ultra?

Possible Side Effects and Safety Information

The officially documented adverse reactions for topical Benzoyl Peroxide (BPO), the active ingredient in this product, are primarily localized to the application site. Regulatory classification systems define the risk profile based on frequency and affected physiological systems.

Frequency-Classified Local Reactions

Government regulatory documents classify skin reactions into distinct frequency tiers:

  • Very Common (Affecting ge 1 in 10 patients): Dry skin, skin peeling or exfoliation, erythema (redness), and a skin burning sensation.
  • Common (Affecting ge 1 in 100 to <1 in 10 patients): Pruritus (itching), stinging, and general skin irritation.

Systemic Reactions and Safety Patterns

The majority of side effects fall under the Skin and Subcutaneous Tissue Disorders category. However, warnings document the potential for rare, serious systemic reactions classified under Immune System Disorders.

Rare, post-marketing reports include severe systemic reactions such as Anaphylaxis and Angioedema (swelling of the face, lips, or throat), which are formally noted in safety warnings. Severe localized reactions, such as blistering or crusting, may warrant discontinuation.

Safety Constraints and Considerations

Official labeling includes mandatory constraints necessary for safe use:

  • Avoidance: Strict avoidance of contact with the eyes, lips, mouth, nostrils, and other mucous membranes is required.
  • Photosensitivity: Warnings advise limiting unnecessary sun exposure, including sunlamps, due to the potential for photosensitivity.
  • Time-Related Pattern: Local skin irritation is officially noted as being more likely to occur during the first few weeks of treatment or when used alongside other topical acne preparations.

Safety notes for specific populations confirm that use during pregnancy or lactation should be discussed with a qualified healthcare professional, citing minimal systemic absorption.

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Overdose and Emergency Response

Overdose and When to Seek Help

Manifestations of Overdose Overdose related to the topical use of this preparation is primarily associated with excessive topical application, which results in an exaggeration of local reactions. Documented manifestations include intense erythema (severe redness), a pronounced burning sensation, and excessive peeling or desquamation of the treated skin. Systemic toxicity is not generally anticipated following topical overuse due to the minimal dermal absorption. However, severe outcomes are associated with the risk of rare, life-threatening hypersensitivity reactions, or the event of accidental oral ingestion of the preparation, both of which require urgent attention.

Required Emergency Actions If symptoms of severe local irritation, such as persistent pain or extreme redness, occur after over-application, the official instruction is to discontinue use immediately and seek medical attention. Any signs of a serious, systemic hypersensitivity reaction, including throat tightness, difficulty breathing, feeling faint, or swelling of the face or tongue, require that the product be stopped and emergency medical attention be sought immediately. In the event of confirmed or suspected accidental oral ingestion, the official requirement is to contact emergency services or a Poison Control Center immediately for clinical management.

Supportive Care and Antidote Status Management for all overdose scenarios is limited to symptomatic and supportive therapy based on the patient’s clinical status. Regulatory documents explicitly state that no specific antidote is known for the active ingredient.

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Therapeutic Uses of Clearasil Ultra

What Clearasil Ultra Treats: Main Uses and Benefits

The active ingredient in this product is commonly used to help with the symptomatic management of mild to moderate acne.

Clearasil Ultra is generally relevant for easing the groups of symptoms that cluster into the physical manifestations of acne. This typically includes treating both inflammatory lesions, such as red, raised papules, and non-inflammatory manifestations like blackheads and whiteheads. Applied in situations where patients experience skin irritation and blemishes, this approach contributes to the overall symptom load and may assist with managing discomfort.

“Applied across domains where additional symptomatic support is needed, this treatment assists with maintaining functional stability when symptoms are more noticeable.”

The treatment is applicable across domains where additional symptomatic support is needed for recurrent or episodic manifestations. It is relevant when short-term symptomatic assistance is needed during an acute breakout, and may also be part of long-term supportive management. By helping to clear existing spots and reduce the development of new ones, the product contributes to easing the overall symptom load during symptomatic periods.

Quick Fact: Supportive Management for Blemishes

Clearasil Ultra is commonly used to address the symptoms of Acne vulgaris, supporting patients who experience both acute, inflamed spots and recurrent clogged pores. It supports patients during episodes of heightened discomfort.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Clearasil Ultra — Official Regulatory Information

The eligibility profile for topical benzoyl peroxide, the active ingredient in Clearasil Ultra, is defined by regulatory agencies based on allergy status, age, and physiological condition.


Eligibility Scope Regulatory Statement
Populations Allowed Adults and adolescents 12 years of age and over have established use under standard labeled conditions.
Contraindicated Use is absolutely prohibited for individuals with a known hypersensitivity or allergy to benzoyl peroxide or any other component in the product.
Age Restriction Use is not recommended in children younger than 12 years; safety and effectiveness have not been established by regulators for this pediatric group.
Pregnancy/Lactation Use during pregnancy is advised only if clearly needed. Caution is advised during breastfeeding, and the product must not be applied to the chest or breast area to prevent accidental infant ingestion.
Conditional Use Individuals with very sensitive skin or skin that is broken, cut, sunburned, or eczematous must not use the product on those areas.

Official regulatory documents define who can and cannot use the medicine, establishing an absolute contraindication for allergy and specific restrictions for age and physiological states. The FDA classifies benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient for acne treatment when used as directed in eligible populations.

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What should I know about interactions with other medicines?

The interaction profile for topical Benzoyl Peroxide, the active ingredient in Clearasil Ultra, is primarily defined by local pharmacodynamic and chemical interactions. Regulatory data consistently indicate a minimal potential for systemic exposure or pharmacokinetic interactions. Therefore, the official information focuses on avoiding combinations that lead to chemical incompatibility or cumulative adverse effects at the application site.

Documented Topical and Chemical Restrictions

  • Topical Sulfone Products: Co-administration with topical sulfone agents (such as dapsone) is officially restricted. This is due to a documented chemical reaction that can cause a temporary local yellow or orange discoloration of the skin and facial hair.
  • Topical Retinoids and Hydroquinone: Use with certain topical retinoid products (like tretinoin) is restricted in some prescribing information because the oxidizing agent can degrade the retinoid, potentially decreasing its intended effectiveness. Co-use with hydroquinone may also result in transient epidermal staining.

Pharmacodynamic and Substance Interactions

Co-application with other topical acne treatments, particularly those classified as peeling, desquamating, or abrasive agents, is restricted due to the documented risk of a cumulative irritancy effect on the skin. Similarly, official documents advise restricting the co-use of skincare products with high concentrations of alcohol due to the documented risk of additive drying and local irritation.

Administration Timing Separation

To mitigate the risk of chemical inactivation or cumulative local adverse effects, official patient guidance recommends administering Clearasil Ultra and any other topical medicine on the same area with a time separation, generally of at least one hour. No systemic food, beverage alcohol, or supplement interactions are officially documented.

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Mechanism of Action

The action of Benzoyl Peroxide (BPO) modulates the key mechanistic components of follicular pathology. The single active ingredient operates via a dual-mechanism to alter the local follicular environment.

Intrafollicular Microbial Oxidation

This domain targets the anaerobic Cutibacterium acnes (C. acnes) bacteria within the pore. The mechanism involves BPO decomposing to release highly reactive free oxygen radicals, initiating a non-specific oxidative reaction. This action causes damage to the bacterial cellular structures, leading to the reduction of the microbial population and indirectly modulates the inflammatory signaling cascade initiated by the organisms.

Modulation of Follicular Epithelial Dynamics

This domain addresses the physical obstruction of the pore. BPO acts as a keratolytic agent, chemically interacting with keratinocytes to accelerate the desquamation of follicular epithelial cells. This key mechanistic step assists in the relief of follicular obstruction and contributes to the establishment of follicular patency, modifying the conditions required for lesion formation.

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Dosage and Administration Information

How to Use Clearasil Ultra: Official Administration Guidelines

The usage of topical benzoyl peroxide, the active ingredient in Clearasil Ultra, is governed by the instructions for Over-the-Counter (OTC) acne drug products. The medicine is designated solely for topical application to the skin, typically available as a cream, gel, or lotion at concentrations up to 10%.


Application Protocol

Application begins with cleansing the skin thoroughly before use. A thin layer of the preparation should be applied to the entire affected area where lesions are present. The official schedule begins with one application daily. This frequency may be gradually increased to a maximum of two or three times daily as the individual tolerates the treatment.

Adjustment and Constraints

Labeled instructions establish a critical adjustment rule: if bothersome dryness or peeling occurs, the user must reduce the application frequency to once a day or every other day. Procedurally, application must avoid contact with the eyes, lips, and mouth. Due to the product's oxidizing nature, users are also advised to avoid contact with hair and dyed fabrics, as this may lead to bleaching.


Age-Specific Use

This topical regimen is officially approved for use by adults and children 12 years of age and older. For any use involving children under the age of 12, the labeling mandates that a doctor be consulted prior to administration. The overall protocol establishes a standardized, controlled approach to using the medication as a non-prescription treatment.

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Recent Clinical Evidence

Evidence for use in Chronic Insomnia

Research was evaluated in short-term randomized controlled trials (RCTs), typically lasting 4 to 12 weeks. These studies monitored patient-reported experiences and objective measurements from sleep studies (polysomnography) to assess short-term or episodic symptom patterns. The populations primarily included adults diagnosed with conditions characterized by functional limitations, such as chronic insomnia.

Findings describe patterns observed in the studies, where research highlights changes measured during the study period. Specifically, studies reported how symptoms evolved in the observed populations, with data indicate patterns related to measurements of subjective and objective sleep latency (the time it takes to fall asleep) and total sleep duration. The evidence contributes to understanding symptom patterns, with some findings describing patient-reported outcomes describing perceived discomfort and restfulness.

However, follow-up durations were limited, meaning long-term effects are not fully established. The existing research provides insight into short-term changes, but the results apply only to the populations studied and reflect the specific conditions under which they were conducted.


Evidence for use in Schizophrenia (Adjunctive Treatment)

Research was studied for its use as an addition to existing standard treatment regimens, primarily through randomized, placebo-controlled trials. Studies explored how symptoms are measured using standardized assessment scales, focusing on outcomes capturing phases of heightened symptom activity and overall symptom intensity over defined time intervals. The populations included adults with persistent manifestations despite ongoing stable treatment.

Findings describe patterns observed in the studies related to changes in symptom scale scores over short time intervals (typically 6 to 12 weeks). Studies report how symptoms evolved in the observed populations, with data indicate patterns related to numeric changes in overall symptom severity and in specific negative symptom measurements when the study agent was added. However, research provides insight into short-term changes only, and findings were mixed across specific symptom domains.


Long-term Studies and Follow-up

This section focuses on evidence that goes beyond the initial short-term study periods. Long-term effects are not fully established for either chronic insomnia or adjunctive schizophrenia treatment. Follow-up durations were limited in the primary trials conducted. This means there is limited information for long-term outcomes, such as the durability of the observed patterns or the persistence of observed symptom patterns over long time intervals. Research is ongoing, but existing studies contribute to the broader evidence landscape by highlighting what is known—and what is still uncertain—about extended use.


Evidence in Special Populations

Evidence in special populations, such as younger individuals (adolescents), older adults, or those with significant co-morbidities (e.g., other medical or mental health conditions), is limited. Sample sizes were modest in the main studies, and research does not determine whether an individual from these specific groups will respond similarly. Data for certain groups remain insufficient, meaning the results apply primarily to the general adult populations studied in the initial trials. Subgroup findings are uncertain, and comparative evidence is lacking for many of these groups.


What is still uncertain about the Research

The research provides context but not individual predictions, and several research limitation frames apply to the body of evidence. Long-term effects are not fully established, particularly concerning functional outcomes and the persistence of observed patterns for both conditions. Sample sizes were modest in many studies, and evidence quality varies across studies. Furthermore, the certainty remains low regarding the translation of changes in standardized measurements (like sleep scores or psychopathology scales) into concrete, daily functioning improvements for every individual. Findings reflect the specific conditions under which they were conducted, and data are still emerging.

Key Studies & References

  1. Clinical Practice Guideline: Schizophrenia and other psychotic disorders (APA)
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Frequently Asked Questions (FAQ)

Common questions about Clearasil Ultra (FAQ)


Q: Can I use this medicine if I am pregnant or planning to be?

Official product information advises that this medicine may cause fetal harm. Therefore, the regulatory label indicates that use of effective contraception is generally advised for women of childbearing potential during treatment. Additionally, the medicine's label generally does not recommend breastfeeding during therapy.


Q: Does this medicine affect my ability to drive or operate machinery?

Regulatory documents indicate that this medicine can cause side effects such as dizziness and somnolence (sleepiness). These effects could potentially impair the ability to drive or safely operate machinery. Patients are generally advised to exercise caution until the full effect of the medicine is known.


Q: Can I suddenly stop taking this medicine?

Official product information cautions against abruptly stopping the medicine. The regulatory label indicates that a gradual reduction in dosage is generally necessary to minimize the risk of withdrawal symptoms, such as anxiety or increased seizure frequency.


Q: Does it make you sleepy or affect your concentration?

Yes, regulatory safety data lists somnolence (sleepiness) and difficulty with concentration/attention as common adverse reactions reported during clinical trials. These are known central nervous system (CNS) effects associated with the medicine, according to official information.


Q: Can this medicine cause allergic reactions like swelling?

Official product information notes that hypersensitivity reactions have been reported with this medicine. These reactions can include angioedema, which is a severe swelling of the face, lips, tongue, or throat. The product label states that if symptoms suggesting an allergic reaction occur, discontinuation of the medicine may be indicated.

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How should Clearasil Ultra be stored and disposed of?

Storage and Disposal Requirements for Clearasil Ultra

Official regulatory documents define specific conditions for storing and disposing of Clearasil Ultra topical products to maintain their stability and ensure safety.

Storage Conditions

  • Temperature: The product must be stored at controlled room temperature, typically 20 °C to 25 °C (68 °F to 77 °F), and should be kept in a cool, dry place.
  • Protection: The container must be kept tightly closed to protect the contents and must not freeze or be exposed to extreme heat. Some formulations must be kept away from open flame.
  • Child Safety: All product containers must be stored out of the reach of children.

Disposal Instructions

Unused or expired medicine should be disposed of via community-based drug take-back programs when available. If not, the product must be mixed with an undesirable substance (e.g., used coffee grounds) and placed in a sealed container before being thrown into the household trash. The product should not be flushed down a toilet or sink.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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