Benzepro Creamy Wash Liquid

Manufacturer PRUGEN Active Ingredient Benzoyl Peroxide Wash and Cleanser(BEN zoe il peer OKS ide) Pronunciation BEN-zoy-il peer-OKS-ide
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anti-acne agent
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Pharmacologic Class
Keratolytic, antibacterial (oxidizing agent), comedolytic
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Benzoyl peroxide is a topical medication used to treat acne. It works by killing the bacteria that cause acne and by helping to unclog pores, reducing blackheads and whiteheads.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.

Application Instructions

Apply this medication directly to the affected skin area only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Wash your hands before and after applying the medication to prevent spreading the medication to other areas.
You can apply makeup after the skin has dried completely.
If you notice the medication or white marks on your skin after application, you may be using too much. Adjust your application amount as needed.

Treatment Duration and Expectations

It may take several weeks to experience the full effects of this medication. Continue using it as directed, even if your symptoms improve.
Use this medication to wash the affected skin area, then rinse with warm water and pat dry.

Storage and Disposal

Store this medication at room temperature in a dry place, away from heat sources. Do not store it in a bathroom.
Be aware of the medication's expiration date or storage duration to ensure you use it within the recommended timeframe.

Missed Dose Instructions

If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Use sunscreen daily, as benzoyl peroxide can increase sun sensitivity.
  • Avoid contact with eyes, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water.
  • Benzoyl peroxide can bleach hair and colored fabrics (towels, clothing, bedding). Use white towels and pillowcases.
  • Apply to clean, dry skin. If using a wash, rinse thoroughly after use.
  • Be patient; it may take several weeks to see improvement.
  • Avoid excessive sun exposure and artificial UV light (tanning beds).

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected areas of the face and/or body once or twice daily. Wet skin, apply wash, gently massage for 1-2 minutes, then rinse thoroughly and pat dry.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

initialUse: Start with once daily application to assess tolerance, then increase to twice daily if well tolerated.
sensitiveSkin: Use less frequently (e.g., every other day) or use a lower concentration product.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years of age without physician consultation due to potential for irritation and lack of specific studies.
Adolescent: Apply to affected areas once or twice daily, similar to adult dosing. Start with once daily to assess tolerance.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Benzoyl peroxide is a potent oxidizing agent that exerts its therapeutic effects in acne vulgaris through multiple mechanisms. It releases free oxygen radicals which are bactericidal against Propionibacterium acnes (now Cutibacterium acnes), the anaerobic bacterium implicated in acne pathogenesis. It also has keratolytic and comedolytic properties, promoting the shedding of dead skin cells and preventing the formation of new comedones (clogged pores).
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Pharmacokinetics

Absorption:

Bioavailability: Minimal (<5% systemically absorbed after topical application)
Tmax: Not clinically significant (topical action)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not clinically significant (minimal systemic absorption)
ProteinBinding: Not clinically significant (minimal systemic absorption)
CnssPenetration: No

Elimination:

HalfLife: Not clinically significant (topical action, rapid metabolism in skin)
Clearance: Not clinically significant (topical action)
ExcretionRoute: Benzoic acid is excreted renally.
Unchanged: Not applicable (metabolized in skin)
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Pharmacodynamics

OnsetOfAction: Days to weeks for noticeable improvement in acne lesions.
PeakEffect: 4-6 weeks of consistent use.
DurationOfAction: Continuous with regular application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor or seek medical help:
- Burning, itching, dryness, or other irritation at the application site
- Stinging
- Scaling
- Peeling
- Feeling of warmth

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning, stinging, or itching
  • Excessive redness or swelling
  • Blistering or crusting of the skin
  • Rash or hives (signs of allergic reaction)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have highly sensitive skin, as this may affect your ability to tolerate the medication.

This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Your existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or significant irritation. To minimize this risk, you may need to follow specific steps before your first use, as directed by your doctor.

To use this medication correctly, follow the instructions provided by your doctor or as outlined on the package label. If you have any questions or concerns, discuss them with your doctor.

Avoid applying this medication to cuts, scrapes, eczema, or damaged skin, as well as sunburned skin. Do not leave the medication on your skin for longer than recommended by your doctor.

Using other skin products in conjunction with this medication may increase the risk of irritation. To help manage skin reactions, moisturize your skin as advised by your doctor.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.

You may be more susceptible to sunburn while using this medication. To protect yourself, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.

When applying this medication, exercise caution, as it may cause bleaching of hair or colored fabrics.

If this medication is swallowed, it can cause harm. In the event of ingestion, immediately contact a doctor or poison control center.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe skin irritation (redness, burning, peeling)
  • Unlikely to cause systemic toxicity due to minimal absorption.

What to Do:

Discontinue use immediately. Wash affected area with mild soap and water. Apply a soothing moisturizer. If irritation persists or is severe, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services.

Drug Interactions

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Moderate Interactions

  • Topical dapsone (may cause temporary yellow/orange skin discoloration)
  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene) - concurrent use may increase irritation and dryness; apply at different times of day (e.g., benzoyl peroxide in morning, retinoid at night).
  • Other topical acne medications (e.g., salicylic acid, sulfur) - increased risk of irritation, dryness, and peeling.
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Minor Interactions

  • Products containing alcohol, astringents, or abrasive soaps (may increase dryness and irritation).

Monitoring

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Baseline Monitoring

Skin assessment (redness, dryness, peeling, irritation)

Rationale: To establish baseline skin condition and identify potential sensitivities before starting treatment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Skin assessment (redness, dryness, peeling, irritation)

Frequency: Daily during initial weeks, then as needed

Target: Mild to moderate dryness/peeling is common and acceptable; severe irritation is not.

Action Threshold: If severe redness, burning, itching, or swelling occurs, discontinue use and consult a healthcare professional.

Acne lesion count/severity

Frequency: Monthly

Target: Reduction in inflammatory and non-inflammatory lesions.

Action Threshold: No improvement after 6-8 weeks, or worsening of condition.

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Symptom Monitoring

  • Excessive dryness
  • Peeling
  • Redness
  • Stinging/burning sensation
  • Itching
  • Swelling (indicative of allergic reaction)

Special Patient Groups

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Pregnancy

Benzoyl peroxide is classified as Pregnancy Category C. While systemic absorption is minimal, use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Minimal systemic absorption suggests low risk, but caution advised.
Second Trimester: Minimal systemic absorption suggests low risk.
Third Trimester: Minimal systemic absorption suggests low risk.
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Lactation

Benzoyl peroxide is considered L3 (moderately safe) during lactation. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in significant amounts. Avoid applying to areas where the infant may come into direct contact with the product (e.g., breast area).

Infant Risk: Low risk of adverse effects in breastfed infants due to minimal maternal systemic absorption.
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Pediatric Use

Generally not recommended for children under 12 years of age without medical supervision due to potential for irritation and lack of specific safety data in this age group. Adolescents (12 years and older) can typically use it following adult dosing guidelines, starting with lower frequency/concentration.

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Geriatric Use

No specific dosage adjustments are needed. However, geriatric patients may have thinner, more fragile, or drier skin, which could increase susceptibility to irritation. Start with a lower concentration and/or less frequent application to assess tolerance.

Clinical Information

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Clinical Pearls

  • Always start with a lower concentration (e.g., 2.5% or 5%) and/or less frequent application (e.g., once daily or every other day) to minimize irritation, especially for new users or those with sensitive skin.
  • Advise patients that initial dryness, redness, and peeling are common and usually subside with continued use as the skin adapts. This is often referred to as the 'purging' phase.
  • Emphasize the importance of consistent use for optimal results; improvement is gradual.
  • Remind patients about the bleaching effect on fabrics and hair.
  • Combine with a non-comedogenic moisturizer to counteract dryness.
  • For washes, ensure adequate contact time (1-2 minutes) before rinsing for efficacy.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Salicylic acid
  • Azelaic acid
  • Oral antibiotics (e.g., doxycycline, minocycline)
  • Oral isotretinoin (for severe acne)
  • Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
  • Chemical peels, laser therapy, light therapy
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Cost & Coverage

Average Cost: $10 - $30 per 4-8 oz bottle
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC), generally not covered by insurance unless specifically prescribed and deemed medically necessary (rare for washes).
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.