SkinActive ingredient
Clindamycin phosphate and benzoyl peroxide
Topical antibacterial combination1 FDA label read
This is the prescription combination that pairs an antibiotic with benzoyl peroxide in one gel. The label records something worth knowing before starting any antibiotic for acne: resistance of the bacteria involved to clindamycin has been documented, and it often travels together with resistance to erythromycin.
Highlights of the labels
- Clindamycin and benzoyl peroxide gel
- Acne vulgariscovers skin
- Supply
- Prescription only
- Generic
- 9 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| Clindamycin and benzoyl peroxide gelOceanside Pharmaceuticals | What its label approvesAcne vulgarisCovers skin | SupplyPrescription | Label version15 August 2025 |
How it works
The label identifies clindamycin as a lincosamide antibacterial and gives the concentration of each of the two ingredients. It does not set out a rationale for combining them, so this page does not supply one either.
Mechanism of action, Clindamycin and benzoyl peroxide gel label
Clindamycin: Clindamycin is a lincosamide antibacterial. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.
What the FDA approved it for
The approved uses, as worded in the label.
Clindamycin Phosphate and Benzoyl Peroxide Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Forms and strengths
The presentations and strengths listed in the label.
- Gel, 1.2%/3.75% Each gram of clindamycin phosphate and benzoyl peroxide gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide in a white to off-white, opaque, smooth gel.
- Gel, 1.2% clindamycin phosphate/3.75% benzoyl peroxide
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Apply a pea-sized amount of clindamycin phosphate and benzoyl peroxide gel to the face once daily.
- Not for oral, ophthalmic, or intravaginal use.
Most common adverse reactions
The adverse reactions the label reports as most common.
most common adverse reactions are: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
Warnings and precautions
The warnings and precautions section of the label.
- Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. Clindamycin Phosphate and Benzoyl Peroxide Gel should be discontinued if significant diarrhea occurs.
- Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
Contraindications
Situations in which the label states the medication must not be used.
- Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.
- Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. Hypersensitivity Clindamycin Phosphate and Benzoyl Peroxide Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.
Drug interactions
Interactions the label singles out.
Avoid using clindamycin phosphate and benzoyl peroxide gel in combination with topical or oral erythromycin-containing products because of its clindamycin component.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
There are no available data on clindamycin phosphate and benzoyl peroxide gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data).
Generic or brand
Generic versions of the clindamycin and benzoyl peroxide combination are approved and available at several strength ratios.
The FDA label database lists 9 approved generic applications for this ingredient.
What affects the cost
This is a prescription product, so what a person pays depends on insurance. This site does not link to sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Generic |
|---|---|
| per gram | Generic$0.671 (range $0.465 to $0.878, 420 listings) |
Median of 420 listings. Effective dates 2025-12-17 to 2026-07-22, file dated 2026-07-29.
What the FDA has changed in these labels
The regulator reissues a label without notice: the old wording simply stops existing. These are the latest revisions on record for the documents this page is built from.
- 4 August 2025Clindamycin and benzoyl peroxide gelfrom the archive
Adverse reactions (1 added, 2 removed)
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Why combine an antibiotic with benzoyl peroxide?
- The label does not answer that. It names both ingredients, gives their concentrations, and separately records that resistance to clindamycin among the bacteria involved in acne has been documented. Anything beyond that would be our explanation rather than the regulator's, so it is not on this page.
- How is it applied?
- The label states a pea-sized amount to the face once daily, and that the product is not for oral, ophthalmic or intravaginal use.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Clindamycin and benzoyl peroxide gel
Oceanside Pharmaceuticals. Label version 6, effective 15 August 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 23 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.