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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
5 Percent Benzoyl Peroxide Cleanser
Generic Name
Benzoyl Peroxide
Active Ingredient
Benzoyl PeroxideCategory
Retinoid [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 50 mg/mL | GEL | TOPICAL | 81136-023 |
Detailed information about 5 Percent Benzoyl Peroxide Cleanser
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for 5 Percent Benzoyl Peroxide Cleanser, you must consult a qualified healthcare professional.
Benzoyl Peroxide is a topical antimicrobial and keratolytic agent primarily used for the treatment of acne vulgaris. As an organic peroxide, it works by introducing oxygen into the pores to eliminate acne-causing bacteria and promote skin shedding.
For the treatment of acne vulgaris, healthcare providers generally recommend starting with a lower concentration (2.5% or 5%) to assess skin tolerance.
Benzoyl Peroxide is generally considered safe for use in children aged 12 years and older. Use in children under 12 should be directed by a pediatrician, as safety and efficacy have not been formally established for all formulations in younger populations.
No dosage adjustment is required for patients with renal impairment due to the minimal systemic absorption of the drug.
No dosage adjustment is required for patients with hepatic impairment.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. However, elderly patients may have increased skin sensitivity and should start with lower concentrations.
If you miss a dose, apply it as soon as you remember. If it is almost time for your next application, skip the missed dose and resume your regular schedule. Do not apply extra medication to make up for a missed dose.
Topical overdose is unlikely but may result in severe skin irritation, swelling, or blistering. If the medication is accidentally ingested, contact a Poison Control Center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or frequency without medical guidance.
Most patients using Benzoyl Peroxide will experience some degree of localized skin reaction, especially during the first 1-3 weeks of treatment:
> Warning: Stop using Benzoyl Peroxide and call your doctor immediately if you experience any of these symptoms of a severe allergic reaction:
There is no evidence that long-term use of Benzoyl Peroxide leads to systemic toxicity. However, chronic use without adequate moisturizing can lead to persistent skin barrier dysfunction and increased sensitivity to environmental factors like wind and cold.
No FDA black box warnings have been issued for Benzoyl Peroxide. However, the FDA has issued a consumer safety communication regarding rare but serious hypersensitivity reactions associated with over-the-counter topical acne products.
Report any unusual or persistent symptoms to your healthcare provider.
Benzoyl Peroxide is for external use only. It must not be used near the eyes, inside the nose or mouth, or on broken or severely irritated skin.
No FDA black box warnings for Benzoyl Peroxide.
There are no specific laboratory monitoring requirements (like blood tests) for Benzoyl Peroxide due to its lack of systemic absorption. Healthcare providers typically monitor the patient's clinical response and skin tolerance during follow-up visits.
Benzoyl Peroxide has no known effect on the ability to drive or operate heavy machinery.
There are no known direct interactions between topical Benzoyl Peroxide and alcohol consumption.
Benzoyl Peroxide can be discontinued without tapering. However, acne symptoms may return if the medication is stopped abruptly before the skin's condition has fully stabilized.
> Important: Discuss all your medical conditions and skin sensitivities with your healthcare provider before starting Benzoyl Peroxide.
There are no systemic drugs that are strictly contraindicated with topical Benzoyl Peroxide. However, it should not be used simultaneously with other products that have similar oxidative or highly irritant properties on the same area of skin.
There are no known food interactions with topical Benzoyl Peroxide as it does not enter the digestive system.
There are no documented interactions between topical Benzoyl Peroxide and oral herbal supplements like St. John's Wort or Ginkgo Biloba.
Benzoyl Peroxide is not known to interfere with standard blood or urine laboratory tests.
> Important: Tell your doctor about ALL medications, supplements, and topical skincare products you are taking or using.
There is potential cross-sensitivity with other peroxide derivatives or benzoic acid esters, though this is rarely reported in clinical literature.
> Important: Your healthcare provider will evaluate your complete medical history and skin type before prescribing Benzoyl Peroxide.
Benzoyl Peroxide is classified as FDA Pregnancy Category C. While animal reproduction studies have not been conducted, systemic absorption is extremely low (under 5%). Most experts, including those at the American College of Obstetricians and Gynecologists (ACOG), consider topical Benzoyl Peroxide to be low-risk during pregnancy when used as directed.
It is unknown whether Benzoyl Peroxide is excreted in human milk. However, due to minimal systemic absorption, it is considered unlikely to pose a risk to the nursing infant. Care should be taken to avoid applying the medication to the breast or nipple area to prevent direct contact with the infant's skin or mouth.
Safety and effectiveness in children below the age of 12 have not been established. In adolescents (12-17), the side effect profile is similar to that of adults, though younger skin may be more prone to irritation.
There is limited data on the use of Benzoyl Peroxide in patients over 65. Because older adults often have thinner, drier skin, healthcare providers may recommend less frequent application or lower concentrations to prevent excessive irritation.
No dosage adjustments are necessary for patients with renal disease. The amount of benzoic acid reaching the kidneys is negligible.
No dosage adjustments are necessary for patients with liver disease, as the drug does not undergo significant hepatic metabolism.
> Important: Special populations require individualized medical assessment and monitoring by a healthcare professional.
Benzoyl Peroxide is a lipophilic oxidizing agent. Its primary molecular target is the cell wall of Cutibacterium acnes. Upon application, it diffuses into the sebaceous follicle and undergoes homolytic cleavage of the peroxide bond, generating free radicals. These radicals induce lipid peroxidation and protein oxidation within the bacterial cell membrane, leading to rapid bactericidal activity. Its keratolytic effect is achieved by increasing the rate of corneocyte desquamation (shedding), which helps clear existing comedones.
Benzoyl Peroxide has a rapid onset of antibacterial action, often reducing C. acnes levels significantly within 48 to 72 hours of initial use. However, visible clinical improvement in acne lesions typically requires 3 to 6 weeks of consistent therapy. It does not exhibit a traditional dose-response relationship in terms of efficacy above 5%, but higher concentrations are associated with increased skin irritation.
| Parameter | Value |
|---|---|
| Bioavailability | < 5% (Topical) |
| Protein Binding | Not clinically significant |
| Half-life | Rapidly metabolized in skin |
| Tmax | Not applicable (Topical) |
| Metabolism | Metabolized to Benzoic Acid in skin |
| Excretion | Renal (as Benzoic Acid) |
Benzoyl Peroxide belongs to the therapeutic class of Antiacne Agents and the pharmacological class of Organic Peroxides. It is often used in combination products with Adapalene (a retinoid) or Clindamycin (a macrolide antibiotic).
Common questions about 5 Percent Benzoyl Peroxide Cleanser
Benzoyl Peroxide is primarily used for the treatment of acne vulgaris, including both inflammatory pimples and non-inflammatory blackheads and whiteheads. It works by killing acne-causing bacteria and helping to clear dead skin cells that clog pores. Healthcare providers may also recommend it for other skin conditions like folliculitis or as part of a combination regimen for rosacea. Because it does not cause bacterial resistance, it is often preferred over long-term topical antibiotics. It is available in various strengths ranging from 2.5% to 10% in both over-the-counter and prescription forms.
The most common side effects of Benzoyl Peroxide are localized skin reactions, including redness, dryness, and peeling. Many users also experience a mild stinging or burning sensation immediately after application, especially during the first few weeks of use. These effects are generally expected as the skin adjusts to the medication and can often be managed by using a non-comedogenic moisturizer. If the redness or peeling becomes severe or painful, healthcare providers usually suggest reducing the frequency of application. More serious reactions, such as intense swelling or blistering, are rare and require medical attention.
Yes, there are no known contraindications or dangerous interactions between topical Benzoyl Peroxide and alcohol consumption. Because the medication is applied to the skin and very little of it enters the bloodstream, alcohol does not interfere with how the drug works. However, heavy alcohol consumption can sometimes contribute to systemic inflammation or skin dehydration, which might indirectly affect your overall skin health. It is always best to maintain a balanced lifestyle while treating skin conditions. If you are using oral medications for acne in addition to Benzoyl Peroxide, check with your doctor regarding alcohol use for those specific drugs.
Benzoyl Peroxide is generally considered low-risk during pregnancy, although it is officially classified as FDA Category C. This classification means that while there haven't been extensive controlled studies in pregnant women, the systemic absorption of the drug through the skin is extremely minimal (less than 5%). Most dermatologists and the American College of Obstetricians and Gynecologists (ACOG) suggest that it is acceptable for use during pregnancy to treat acne. However, it is always recommended to consult with your obstetrician or healthcare provider before starting any new medication while pregnant. They can help you weigh the benefits against any potential risks based on your specific health history.
While Benzoyl Peroxide begins killing bacteria on the skin almost immediately, visible improvement in acne typically takes 3 to 6 weeks of consistent daily use. Some patients may even experience a slight worsening of their skin during the first week as the medication begins to clear out clogged pores. Full therapeutic results are often not seen until 8 to 12 weeks of treatment. It is important to continue using the medication as directed by your healthcare provider, even if you do not see immediate changes. If there is no improvement after 3 months, your doctor may suggest adjusting the concentration or adding another treatment.
Yes, you can stop using Benzoyl Peroxide suddenly without experiencing physical withdrawal symptoms or dangerous side effects. However, because Benzoyl Peroxide manages acne rather than curing it permanently, stopping treatment may result in the return of acne lesions. Many healthcare providers recommend a maintenance schedule, such as applying the product every other day, once the skin has cleared. If you decide to stop using it, monitor your skin closely for new breakouts. Discuss a long-term skincare plan with your dermatologist to ensure your skin remains clear after discontinuing the product.
If you miss a dose of Benzoyl Peroxide, simply apply it as soon as you remember. If it is nearly time for your next scheduled application, skip the missed dose and continue with your regular routine. You should not apply a double amount of the medication to make up for a missed application, as this can significantly increase the risk of skin irritation, redness, and peeling. Consistency is key for treating acne, but occasional missed doses will not significantly impact the long-term effectiveness of the treatment. Try to incorporate the application into your daily morning or evening hygiene routine to help you remember.
No, topical Benzoyl Peroxide does not cause weight gain. Because the medication is applied to the skin and has negligible systemic absorption, it does not affect your metabolism, hormones, or appetite. Weight gain is not listed as a side effect in any clinical trials or FDA-approved labeling for this drug. If you are experiencing unexpected weight changes while using Benzoyl Peroxide, they are likely due to other factors such as diet, lifestyle, or other medications you may be taking. You should discuss any concerns about weight changes with your primary care physician.
Benzoyl Peroxide can be used alongside many other medications, but some topical combinations require caution. For example, using it at the same time as tretinoin (Retin-A) can cause the tretinoin to break down and become less effective, so they should be applied at different times of the day. Using it with topical dapsone can cause a temporary orange stain on the skin. Additionally, combining it with other irritating treatments like salicylic acid may lead to excessive dryness. Always provide your healthcare provider with a full list of all medications and skincare products you are currently using to avoid potential interactions.
Yes, Benzoyl Peroxide is widely available as a generic medication and is also the active ingredient in many well-known over-the-counter brand-name products. Generic versions are required by the FDA to have the same quality, strength, and purity as brand-name versions. You can find generic Benzoyl Peroxide in various forms, including gels, washes, and creams, often at a significantly lower cost than brand-name equivalents. Many prescription combination products that contain Benzoyl Peroxide (such as those mixed with clindamycin or adapalene) also have generic versions available. Check with your pharmacist to find the most cost-effective option for your treatment plan.
Other drugs with the same active ingredient (Benzoyl Peroxide)