Key facts
- Active ingredient
- Benzoyl Peroxide and Clindamycin Phosphate
- Form
- Topical, Kit
- Strength
- Benzoyl Peroxide 2.5%; Clindamycin Phosphate EQ 1.2% Base
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Encube
- Half-life
- about 2.4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.05 per gm — not your price
- FDA application
- ANDA207194
What is Clindamycin Phosphate and Benzoyl Peroxide?
From the FDA label:Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7 chloro-6,7,8-trideoxy- 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo a-D-galacto octopyranoside 2- (dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate: Molecular Formula: C 18 H 34 CIN 2 O 8 PS Molecular Weight: 504.97 Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below: Benzoyl peroxide: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% contains the following inactive ingredients: carbopol 980, poloxamer 182, polysorbate 80, propylene glycol, purified water and sodium hydroxide. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin. clinda-str benzoyl-str
How to use
Clindamycin Phosphate and Benzoyl Peroxide is sold in more than one form (Topical and Kit), and each is dosed differently. The instructions below come from the FDA label for application ANDA207194 — follow the label that came with the product you were actually prescribed.
Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% to the face once daily. Use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% beyond 12 weeks has not been evaluated. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% is not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% to the face once daily. (2) • Not for oral, ophthalmic, or intravaginal use. (2)
Side effects
The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of patients treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5%: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of subjects that had symptoms…
Warnings
Important safety information
Colitis: Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% should be discontinued if significant diarrhea occurs. (5.1) • Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. (5.2) 5.1 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. When significant diarrhea occurs, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% should be discontinued. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. 5.2 Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application [ See Nonclinical Toxicology ( 13.1 ) ].
Who should not take Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide Gel,1.2% / 2.5% is contraindicated in: • Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic–associated colitis. (4) 4.1 Hypersensitivity Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5%. [ See Postmarketing Experience ( 6.2 ) .] 4.2 Colitis/Enteritis Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. [ see Warnings and Precautions ( 5.1 ) ].
Interactions
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% should not be used in combination with erythromycin containing products because of its clindamycin component. (7.1) 7.1 Erythromycin Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known. 7.2 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2% / 2.5% should be used with caution in patients receiving such agents.
How long does Benzoyl Peroxide and Clindamycin Phosphate stay in your body?
The elimination half-life of benzoyl peroxide and clindamycin phosphate is about 2.4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label gives an average biological (elimination) half-life of 2.4 hours for oral clindamycin hydrochloride, the active form. It runs slightly longer in older adults (about 4.0 hours, range 3.4–5.1, vs 3.2 hours, range 2.1–4.2, in younger adults) and is increased slightly in people with markedly reduced kidney or liver function. Clindamycin palmitate (oral pediatric solution) and clindamycin phosphate (injection) are inactive prodrugs that are hydrolyzed in the body to this same active clindamycin. Half-life reflects how fast the drug leaves the blood, not how long a drug test can detect it.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride) capsule — FDA label, DailyMed.
Dosage forms
Topical and Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Frequently asked questions
- How much does Clindamycin Phosphate and Benzoyl Peroxide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.05 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Clindamycin Phosphate and Benzoyl Peroxide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Clindamycin Phosphate and Benzoyl Peroxide. To pay less, Clindamycin Phosphate and Benzoyl Peroxide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Clindamycin Phosphate and Benzoyl Peroxide?
- Clindamycin Phosphate and Benzoyl Peroxide is marketed by Encube. You can see Encube's full profile, rating, and other products on pharmaranks.
- Is Clindamycin Phosphate and Benzoyl Peroxide a brand-name or generic drug?
- Clindamycin Phosphate and Benzoyl Peroxide is a generic medication; its active ingredient is Benzoyl Peroxide and Clindamycin Phosphate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Clindamycin Phosphate and Benzoyl Peroxide available over the counter?
- No. Clindamycin Phosphate and Benzoyl Peroxide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Clindamycin Phosphate and Benzoyl Peroxide come in?
- Clindamycin Phosphate and Benzoyl Peroxide is currently marketed as topical and kit, per the FDA's National Drug Code Directory.
- Is Clindamycin Phosphate and Benzoyl Peroxide FDA-registered?
- Clindamycin Phosphate and Benzoyl Peroxide is on record with the U.S. FDA under application number ANDA207194. You can verify this on its official FDA label.
- Is Clindamycin Phosphate and Benzoyl Peroxide safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Clindamycin Phosphate and Benzoyl Peroxide. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Clindamycin Phosphate and Benzoyl Peroxide?
- Clindamycin Phosphate and Benzoyl Peroxide's side effects are taken directly from its FDA label. From the label: The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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