Benzac-5 Gel 60gm
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Keratolytic, antibacterial (oxidizing agent)
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benzoyl peroxide is a topical medicine used to treat acne. It works by killing the bacteria that cause acne and by helping to remove dead skin cells that can clog pores.
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.
Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Before and after applying the medication, wash your hands 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 accordingly.
It may take several weeks to experience the full effects of the medication. Continue using it as directed, even if your symptoms improve.
Before applying the medication, clean the affected area and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
* Depending on your doctor's instructions, you may need to rinse the affected skin after a certain period.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms and areas exposed to heat. Be aware of the medication's expiration date or the duration for which it can be stored before disposal.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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.
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.
Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Before and after applying the medication, wash your hands 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 accordingly.
It may take several weeks to experience the full effects of the medication. Continue using it as directed, even if your symptoms improve.
Before applying the medication, clean the affected area and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
* Depending on your doctor's instructions, you may need to rinse the affected skin after a certain period.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms and areas exposed to heat. Be aware of the medication's expiration date or the duration for which it can be stored before disposal.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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.
Lifestyle & Tips
- Apply to clean, dry skin.
- Avoid contact with eyes, mouth, nostrils, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Avoid contact with hair and colored fabrics (e.g., clothing, bedding, towels) as benzoyl peroxide can bleach them.
- Use sunscreen daily, as benzoyl peroxide can increase sensitivity to the sun.
- Avoid excessive sun exposure and artificial UV light (tanning beds).
- Do not use on broken, irritated, or sunburned skin.
- Start with a lower concentration or less frequent application if skin irritation occurs, then gradually increase as tolerated.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once or twice daily
Condition-Specific Dosing:
initial_therapy:
Start with once daily application, gradually increasing to twice daily if tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 12 years and older: Apply a thin layer to affected areas once or twice daily. For younger children, consult a physician.
Adolescent:
Apply a thin layer to affected areas once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Dialysis:
No specific considerations (topical application, minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Pharmacology
Mechanism of Action
Benzoyl peroxide is an oxidizing agent that releases free oxygen radicals, which are bactericidal against Propionibacterium acnes (now Cutibacterium acnes), the bacteria implicated in acne vulgaris. It also has keratolytic and comedolytic effects, promoting the shedding of dead skin cells and preventing the formation of new comedones.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic after topical application)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (primarily local action, benzoic acid rapidly eliminated)
Clearance:
Not applicable (primarily local action)
ExcretionRoute:
Renal (as benzoic acid)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Visible improvement typically within 3-4 weeks, full effect may take 8-12 weeks.
PeakEffect:
8-12 weeks
DurationOfAction:
Continuous use required for sustained effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
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. While 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 symptoms that bother you or do not go away, contact your doctor:
Burning, itching, dryness, or other irritation at the application site
Stinging
Scaling
Peeling
Feeling of warmth
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
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. While 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 symptoms that bother you or do not go away, contact your doctor:
Burning, itching, dryness, or other irritation at the application site
Stinging
Scaling
Peeling
Feeling of warmth
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning
- Stinging
- Itching
- Blistering
- Swelling
- Excessive redness or peeling
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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.
If you have highly sensitive skin.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication with your other drugs and health conditions.
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.
If you have highly sensitive skin.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication with your other drugs and health conditions.
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 healthcare provider.
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. Additionally, do not apply it to sunburned skin. Only leave the medication on your skin for the duration 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 drugs or products on your skin, including soaps, consult with your doctor.
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 ingested, it can cause harm. If you or someone else swallows this medication, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
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 healthcare provider.
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. Additionally, do not apply it to sunburned skin. Only leave the medication on your skin for the duration 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 drugs or products on your skin, including soaps, consult with your doctor.
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 ingested, it can cause harm. If you or someone else swallows this medication, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe skin irritation (redness, burning, stinging, peeling)
- Unlikely to cause systemic toxicity due to minimal absorption.
What to Do:
Discontinue use immediately. Apply cool compresses. If irritation is severe or persistent, consult a healthcare professional. Call 1-800-222-1222 for poison control advice if ingested or severe reaction occurs.
Drug Interactions
Moderate Interactions
- Dapsone (topical): Concurrent use may cause temporary yellow or orange discoloration of the skin and facial hair.
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene): Benzoyl peroxide can oxidize and inactivate some retinoids. If used together, apply at different times of day (e.g., retinoid at night, benzoyl peroxide in the morning).
Minor Interactions
- Other topical acne products (e.g., salicylic acid, sulfur): May increase skin irritation, dryness, or peeling.
Monitoring
Baseline Monitoring
Skin condition (redness, dryness, peeling, irritation)
Rationale: To assess baseline tolerance and guide initial dosing.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin condition (redness, dryness, peeling, irritation)
Frequency: Daily during initial weeks, then as needed
Target: Mild to moderate dryness/peeling is expected; severe irritation warrants dose reduction or temporary discontinuation.
Action Threshold: Severe burning, itching, blistering, or swelling: discontinue use and seek medical advice.
Acne lesion count/severity
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: No improvement after 12 weeks or worsening of condition: re-evaluate treatment plan.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Stinging
- Burning sensation
- Itching
- Swelling
- Blistering (rare, indicates severe irritation/allergic reaction)
Special Patient Groups
Pregnancy
Benzoyl peroxide is classified as Pregnancy Category C. While systemic absorption is minimal, use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption, but caution advised. Data are limited.
Second Trimester:
Minimal systemic absorption, generally considered low risk.
Third Trimester:
Minimal systemic absorption, generally considered low risk.
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 medication (e.g., breast area).
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Generally safe for use in adolescents and children 12 years and older. For younger children, use should be under medical supervision due to potential for increased skin sensitivity and lack of extensive studies.
Geriatric Use
No specific dose adjustments are typically needed. However, geriatric patients may have thinner or more sensitive skin, which could increase the likelihood of irritation. Start with lower concentrations and monitor skin response closely.
Clinical Information
Clinical Pearls
- Benzoyl peroxide can cause significant skin dryness, redness, and peeling, especially during the initial weeks of treatment. Advise patients to start with a lower concentration (e.g., 2.5% or 5%) and/or apply less frequently (e.g., every other day) to allow the skin to adapt.
- Always advise patients to use a non-comedogenic moisturizer and a broad-spectrum sunscreen daily, as benzoyl peroxide can increase sun sensitivity and dryness.
- Warn patients about the bleaching effect on hair, clothing, and fabrics. Advise application before bed and using white towels/pillowcases.
- For optimal results, benzoyl peroxide should be applied to the entire affected area, not just individual lesions.
- It is often used in combination with other acne treatments (e.g., topical retinoids, antibiotics), but care must be taken to avoid excessive irritation or inactivation of other agents (e.g., apply at different times of day).
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Salicylic acid (topical)
- Azelaic acid (topical)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives for females)
- Chemical peels
- Laser/light therapies
Cost & Coverage
Average Cost:
Typically $5 - $30 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it is an over-the-counter (OTC) product. May be covered by some FSA/HSA plans.
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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.