Fixed-dose combination
Adapalene, Benzoyl peroxide and Clindamycin is a fixed-dose combination of a lincosamide antibacterial and a retinoid indicated for the topical treatment of acne vulgaris in adult, among other approved uses. MedsAcross supplies Adapalene, Benzoyl peroxide and Clindamycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. 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.
Source: US FDA prescribing information
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. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.
Source: US FDA prescribing information
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. Apply a thin layer of CABTREO to the affected areas once daily.
Source: US FDA prescribing information
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. History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Source: US FDA prescribing information
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
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity Colitis Skin Irritation and Allergic Contact Dermatitis The 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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Prior to Dispensing: Store CABTREO in a refrigerator between 2° to 8°C (36° to 46°F) until dispensed to the patient. After Dispensing: Store CABTREO at room temperature at or below 25°C (77°F). Do not freeze. Store pump upright.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Adapalene, Benzoyl peroxide and Clindamycin, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Cabtreo 1.5 mg/31 mg/12 mg per g gelTopical Cold chain | Adapalene, Benzoyl peroxide and Clindamycin | Bausch Health | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 October 2023 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Adapalene, Benzoyl peroxide and Clindamycin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Adapalene, Benzoyl peroxide and Clindamycin, including Cabtreo.
Yes. The US FDA first approved Adapalene, Benzoyl peroxide and Clindamycin on 20 October 2023, according to Drugs@FDA.
At least one listed presentation of Adapalene, Benzoyl peroxide and Clindamycin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.