FDA-filed SPL labeling · retrieved through openFDA

Clindamycin and Benzoyl Peroxide Topical

Clindamycin and benzoyl peroxide is a two-ingredient topical combination used to treat acne vulgaris.

Brand names OnextonBenzaclinNeuacAcanyaNeuac Kit
Drug class ⓘ Lincosamide Antibacterial
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 33 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveSep 30, 2020
Clinical labels in scope ⓘ33
AvailabilityRx
Earliest approval/marketing year ⓘ2009
FDA-listed product records ⓘ83
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 16, 2026
⭐ Clindamycin and Benzoyl Peroxide Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Clindamycin and benzoyl peroxide gel is an effective topical combination for treating acne vulgaris in people 12 and older, applied once daily to the face. Apply only a small amount, keep it away from eyes and mouth, and minimize sun exposure after use. The most important safety concern is the rare but serious risk of colitis — stop use and call your doctor if you develop severe diarrhea.
How we write & review this content — our editorial policy →

📖 Clindamycin and Benzoyl Peroxide Topical: Patient Information Guide

A plain-language walkthrough of Clindamycin and Benzoyl Peroxide Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Clindamycin and benzoyl peroxide topical is a combination gel used to treat acne directly on the skin.

  • Clindamycin Phosphate and Benzoyl Peroxide Gel (1.2%/3.75%) is approved for the topical treatment of acne vulgaris in patients 12 years of age and older
⚙️How it works▾

This gel combines two ingredients that fight acne in different ways. Clindamycin is an antibacterial that attaches to bacteria and stops them from making proteins — essentially shutting down their ability to grow and survive. Benzoyl peroxide is an oxidizing agent that kills bacteria on the skin and has keratolytic effects, meaning it helps break up the buildup of dead skin cells that can block pores. Both ingredients have shown activity against Propionibacterium acnes (now also called Cutibacterium acnes), a bacterium closely linked to acne development.

It's worth knowing that P. acnes can develop resistance to clindamycin over time, and resistance to clindamycin is often linked to resistance to erythromycin as well. This is one reason the combination formula is used — to help reduce the chance of resistance developing.

💊How it's taken▾

Apply this gel to the face once daily, using only a pea-sized amount. Before applying, wash your face gently with a mild soap, rinse with warm water, and pat dry.

  • For skin use only — keep away from eyes, mouth, mucous membranes, and broken skin
  • Use beyond 12 weeks has not been evaluated; follow your prescriber's guidance on duration
  • If you miss a dose, apply it as soon as you remember — but if it's almost time for your next application, skip the missed one and resume your usual schedule
🤒Side effects — in detail▾

Most side effects with this gel are mild and happen on the skin where you apply it.

  • Burning sensation
  • Contact dermatitis (skin irritation or inflammation at the application site)
  • Itching (pruritus)
  • Rash
  • Redness (erythema)
  • Scaling or flaking skin
  • Stinging

Local skin reactions like redness, scaling, and burning tend to peak around week 4 and improve by week 12. However, if you develop severe or persistent diarrhea, bloody stools, or severe stomach cramps, stop using the gel and contact your doctor right away — this could signal a serious condition called colitis.

⚠️Warnings & precautions▾
  • Colitis risk: Clindamycin can be absorbed through the skin even when applied topically. Serious colon inflammation — including pseudomembranous colitis (a dangerous infection caused by Clostridioides difficile bacteria) — has been reported. Severe colitis can be life-threatening. Stop using the gel immediately and call your doctor if you develop significant diarrhea, bloody stools, or severe abdominal cramps. Do not take anti-diarrheal medicines like loperamide without medical guidance, as they may worsen the condition.
  • Sun sensitivity: Minimize sun exposure, tanning beds, and sun lamps after applying this medication.
  • Skin irritation from combining products: Using other acne treatments at the same time — especially peeling, scrubbing, or drying agents — can increase skin irritation. Reduce application frequency or take a break if your skin becomes very irritated. Discontinue if irritation does not resolve.
🔀What it interacts with▾

There are a few important interactions to know about with this gel.

  • Erythromycin (topical or oral): Do not use together — lab studies show these two antibacterials can work against each other, which could reduce effectiveness
  • Neuromuscular blocking agents (medicines used during anesthesia to relax muscles): Clindamycin may strengthen their muscle-relaxing effects; use with caution and make sure your medical team knows you use this gel before any procedure
  • Other topical acne products (especially peeling, desquamating, or abrasive agents): Combining them can cause cumulative skin irritation; use with caution

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not use if you have ever had a serious allergic reaction — including anaphylaxis (life-threatening allergic reaction) — to clindamycin, benzoyl peroxide, lincomycin, or any ingredient in the product
  • Do not use if you have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis
  • Tell your doctor if you are pregnant — there are no reliable safety studies of this specific topical gel in pregnant women; discuss the risks and benefits with your provider
  • If you are breastfeeding and apply this product to the chest, take care to prevent your infant from accidentally ingesting it; clindamycin has been detected in breast milk following oral and injectable use
  • Not evaluated in children under 12 years old — safety and effectiveness in this age group are unknown
  • Not enough data exist to determine if adults 65 and older respond differently than younger patients
🔬Pharmacokinetics — how your body processes it▾

Some clindamycin from this gel is absorbed through the skin into the bloodstream, though the amount is very small. In a study of adults with moderate to severe acne using a similar gel once daily for 30 days, measurable clindamycin blood levels were detected in most participants, but levels were undetectable 24 hours after each dose — meaning it does not meaningfully build up in the body between daily applications.

Benzoyl peroxide is also absorbed through the skin, where it is converted to benzoic acid. The full extent of systemic absorption for the specific 1.2%/3.75% gel formulation has not been formally evaluated.

📦How to store it▾

Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Store at 20° to 25°C (68° to 77°F) . Protect from freezing.

📄 Written from Clindamycin and Benzoyl Peroxide Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Clindamycin and Benzoyl Peroxide Topical — the kind of thing our pharmacy team would talk through with you at the counter.

What is this gel actually supposed to do for my acne? ▾
It treats acne vulgaris — regular acne — by attacking the bacteria on your skin and helping to clear clogged pores. The clindamycin fights the bacteria that contribute to breakouts, while the benzoyl peroxide kills bacteria and helps loosen dead skin cells. Used together once a day, they work better than either ingredient would alone.
How do I apply it correctly? ▾
Start by washing your face gently with a mild soap, rinsing with warm water, and patting it completely dry. Then apply just a pea-sized amount — that's really all you need — and spread it over your face once a day. Keep it away from your eyes, mouth, and any broken skin. It's for skin use only, so don't use it in or around the eyes or mouth.
My skin is getting red and irritated — is that normal? ▾
Some redness, burning, itching, and flaking in the first few weeks is common and usually means your skin is adjusting. These reactions often peak around week 4 and tend to improve on their own by week 12. If irritation is really bothering you, you can try applying it less often until it settles down. But if the irritation stays severe or doesn't improve, let your doctor know — you may need to stop.
I've heard something about diarrhea being a concern — should I be worried? ▾
It's worth knowing about, even though this is a skin product. Clindamycin can be absorbed through the skin in small amounts, and in rare cases it can affect the gut — causing diarrhea, bloody stools, or serious colon inflammation called colitis. If you develop significant diarrhea or severe stomach cramps while using this gel, stop applying it and call your doctor right away. Don't take anti-diarrhea medicines without asking your doctor first, as they could make things worse.
Can I use other acne products or treatments at the same time? ▾
You need to be careful here. Using other acne products — especially ones that peel, exfoliate, or dry the skin — alongside this gel can cause extra irritation. Also, do not use any products containing erythromycin (a different antibiotic) at the same time, because it can interfere with how well the clindamycin works. Always check with your prescriber before adding anything new to your acne routine.
Is it safe to use if I'm pregnant or breastfeeding? ▾
There isn't enough data from studies to say definitively whether this topical gel is safe during pregnancy, so it's a conversation to have with your doctor — they'll weigh the benefit for you against any potential risk. If you're breastfeeding and applying it to your chest, be careful to make sure your baby can't accidentally get it in their mouth. Talk to your doctor or pharmacist about the best approach for your situation.
Is Clindamycin and Benzoyl Peroxide Topical available over the counter? ▾
Clindamycin and Benzoyl Peroxide Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Clindamycin and Benzoyl Peroxide Topical first available? ▾
Clindamycin and Benzoyl Peroxide Topical has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Clindamycin and Benzoyl Peroxide Topical? ▾
Clindamycin and Benzoyl Peroxide Topical is supplied by 20 manufacturers listed in the FDA NDC Directory, including Padagis Israel Pharmaceuticals Ltd, Bryant Ranch Prepack, Taro Pharmaceuticals U.S.A., Inc..

💬 Answers drafted from Clindamycin and Benzoyl Peroxide Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Clindamycin and Benzoyl Peroxide Topical comes

Clindamycin and Benzoyl Peroxide Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Acanya Benzaclin Neuac Onexton
How this form is used
What it may be used for
  • Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
Important instructions
  • Clindamycin Phosphate and Benzoyl Peroxide Gel: before applying, gently wash your face with a mild soap, rinse with warm water, and pat skin dry
  • Clindamycin Phosphate and Benzoyl Peroxide Gel: apply a pea-sized amount to the face once daily
  • Clindamycin Phosphate and Benzoyl Peroxide Gel: avoid contact with the eyes, mouth, mucous membranes, and broken skin
  • Clindamycin Phosphate and Benzoyl Peroxide Gel: for skin use only — not for oral, eye, or vaginal use
Available strengths 7 strengths
10 mg/g / 25 mg/g 10 mg/g / 37.5 mg/g 10 mg/g / 50 mg/g 25 mg/g / 10 mg/g 37.5 mg/g / 10 mg/g 50 mg/g / 10 mg/g
Show 1 more strength Show fewer strengths
50 mg/g / 12 mg/g
54 FDA-listed product records ⓘ

📊 Clindamycin and Benzoyl Peroxide Topical across the U.S. market

How Clindamycin and Benzoyl Peroxide Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
20
Manufacturers
8
Brand names
83
FDA-listed product records ⓘ
2009
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Kit (29) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Padagis Israel Pharmaceuticals Ltd16%
Bryant Ranch Prepack12%
Taro Pharmaceuticals U.S.A., Inc.10%
Sun Pharmaceutical Industries, Inc.8%
Mylan Pharmaceuticals Inc.7%
Glenmark Pharmaceuticals Inc., USA7%
Other makers40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Clindamycin and Benzoyl Peroxide Topical is used

A general measure of how commonly Clindamycin and Benzoyl Peroxide Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Clindamycin and Benzoyl Peroxide Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

299,589
Medicaid prescriptions filled (Q1–Q4 2025)
$13.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Clindamycin and Benzoyl Peroxide Topical prescribed? Of the 1,594 medications we measure, Clindamycin and Benzoyl Peroxide Topical ranks #324 by Medicaid prescriptions — more than 80% of them.

Where Clindamycin and Benzoyl Peroxide Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #324 of 1,594
#319 Temazepam 303,646 Rx #320 Nitroglycerin Sublingu... 303,475 Rx #321 Methoxy Polyethylene G... 301,411 Rx #322 Torsemide 301,185 Rx #323 Galcanezumab-gnlm Inje... 300,085 Rx #324 Clindamycin and Benzoy... 299,589 Rx #325 Ethinyl Estradiol / Et... 298,425 Rx #326 Ipratropium Oral Inhal... 298,032 Rx #327 Donepezil 295,048 Rx #328 Mirabegron 293,458 Rx #329 Mycophenolate 292,779 Rx

Utilization by Clindamycin and Benzoyl Peroxide Topical product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Clindamycin and Benzoyl Peroxide Topical products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

299,589 Medicaid prescriptions (Q1–Q4 2025) 100% of Clindamycin and Benzoyl Peroxide Topical prescriptions shown $13.3M gross reimbursement (before rebates) ≈ $44 per prescription (gross)

Summed across the 33 of 56 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Clindamycin and Benzoyl Peroxide Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 33 of 56 listed Clindamycin and Benzoyl Peroxide Topical NDCs with Medicaid activity.

🔍 Compare Clindamycin and Benzoyl Peroxide Topical products

A representative set of FDA-listed product records for Clindamycin and Benzoyl Peroxide Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 83 of 83 products — FDA National Drug Code Directory. See every product, package size and price: browse all 83 Clindamycin and Benzoyl Peroxide Topical NDCs →

🏷️ Sold under these brand names

Onexton Benzaclin Neuac Acanya Neuac Kit

🏭 Manufacturers & labelers

Padagis Israel Pharmaceuticals Ltd 13 Bryant Ranch Prepack 10 Taro Pharmaceuticals U.S.A., Inc. 8 Sun Pharmaceutical Industries, Inc. 7 Mylan Pharmaceuticals Inc. 6 Glenmark Pharmaceuticals Inc., USA 6 Sandoz Inc. 5 Encube Ethicals, Inc. 4 Oceanside Pharmaceuticals 4 Bausch Health US, LLC 3 NorthStar RxLLC 3 Medimetriks Pharmaceuticals 3 Bausch Health US LLC 2 Zydus Lifesciences Limited 2 Actavis Pharma, Inc. 2 Zydus Pharmaceuticals USA Inc. 1 Remedyrepack Inc. 1 Encube Ethicals Private Limited 1 Northstar Rx LLC 1 Mayne Pharma 1

RxNorm drug class

Clindamycin and Benzoyl Peroxide Topical belongs to the Peroxides class.

Drug family (ATC) Peroxides

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 30, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Clindamycin and Benzoyl Peroxide Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Clindamycin and Benzoyl Peroxide Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
33
NDC products indexed
83
Distinct labelers/manufacturers represented
20
Linked representative label ⓘ
Oceanside Pharmaceuticals
Linked label effective
Sep 30, 2020
Composite sections available
21
Linked SPL Set ID
edae294f-cc8b-4f94-8d90-4c764fda307b
Linked SPL Document ID
18705773-78c3-4eac-a1a7-f4ac6f667ef2
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 33 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Oceanside Pharmaceuticals is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.