SkinActive ingredient
Clindamycin, adapalene and benzoyl peroxide
Antibacterial, retinoid and oxidizing agent, fixed combination1 FDA label read
Sold as Cabtreo, this is the only triple-combination acne product on these pages: a lincosamide antibacterial, a retinoid and benzoyl peroxide in one gel, approved for acne in patients 12 years of age and older. Each of its three components also exists on this site separately or in two-ingredient combinations.
Highlights of the labels
- Cabtreo
- Acne in patients 12 and oldercovers skin
- Supply
- Prescription only
- Generic
- None approved
- 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 |
|---|---|---|---|
| CabtreoBausch Health US LLC | What its label approvesAcne in patients 12 and olderCovers skin | SupplyPrescription | Label version24 April 2025 |
How it works
The label describes each component in its own terms: clindamycin is a lincosamide antibacterial, adapalene binds specific retinoic acid nuclear receptors, benzoyl peroxide is an oxidizing agent. The gel is applied once daily as a thin layer to cleansed, dry skin.
Mechanism of action, Cabtreo label
Clindamycin: Clindamycin is a lincosamide antibacterial. Adapalene: Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes.
What the FDA approved it for
The approved uses, as worded in the label.
CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.
Forms and strengths
The presentations and strengths listed in the label.
- Topical gel: 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide as a white to off-white, opaque gel.
- CABTREO is supplied in 20-gram and 50-gram pumps.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Cleanse the affected area gently.
- After the skin is dry, apply a thin layer of CABTREO to the affected area once daily.
- Wash hands thoroughly after application of CABTREO.
- Avoid the eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous, or sunburned skin.
- CABTREO is for topical use only.
- Not for oral, ophthalmic, or intravaginal use.
Most common adverse reactions
The adverse reactions the label reports as most common.
most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.
Warnings and precautions
The warnings and precautions section of the label.
- Hypersensitivity: If a serious hypersensitivity reaction occurs, discontinue CABTREO immediately and initiate appropriate therapy.
- Colitis: Clindamycin can cause severe colitis, which may result in death. Discontinue CABTREO if diarrhea occurs.
- Photosensitivity: Avoid or minimize exposure to sunlight and sunlamps. Wear sunscreen and protective clothing when sun exposure cannot be avoided.
- Skin Irritation and Allergic Contact Dermatitis: Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of CABTREO and may necessitate discontinuation
Contraindications
Situations in which the label states the medication must not be used.
- CABTREO is contraindicated in patients with: Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components of CABTREO, or lincomycin.
- A history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
- Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any components of the formulation, or lincomycin.
Drug interactions
Interactions the label singles out.
- Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
- Use CABTREO with caution in patients receiving such agents.
- Neuromuscular Blocking Agents: Use CABTREO with caution in patients receiving neuromuscular blocking agents.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Available data with CABTREO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with CABTREO.
Generic or brand
There is no FDA-approved generic of this triple combination: the register lists no generic application for it. The two-ingredient clindamycin and benzoyl peroxide combination, covered on its own page here, does have generics.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Cabtreo is brand-only and new enough that the CMS pricing set lists no acquisition figures for it yet. The two-ingredient combination it extends has generic pricing on its own page here. This site sells nothing and links to no sellers.
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
- What is in Cabtreo?
- Three active ingredients: clindamycin phosphate, adapalene and benzoyl peroxide. The label identifies them as a lincosamide antibacterial, a retinoid and an oxidizing agent respectively.
- How does Cabtreo differ from clindamycin and benzoyl peroxide gel?
- By one ingredient: Cabtreo adds adapalene, a retinoid, to the same antibacterial-plus-benzoyl-peroxide pair. Both are once-daily gels for acne from age 12. The comparison page sets the two labels side by side.
- What are the serious warnings on the label?
- The clindamycin component brings a colitis warning - the label states clindamycin can cause severe colitis, which may result in death, and instructs discontinuing if significant diarrhea occurs. Hypersensitivity and photosensitivity warnings are also quoted on this page.
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 Cabtreo
Bausch Health US LLC. Label version 6, effective 24 April 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.