Key facts
- Active ingredient
- Clindamycin Phosphate and Tretinoin
- Form
- Topical
- Strength
- Clindamycin Phosphate 1.2%; Tretinoin 0.025%
- 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
- ~$0.18 per gm — not your price
- FDA application
- ANDA216943
What is Clindamycin Phosphate and Tretinoin?
From the FDA label:Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. 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 -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for tretinoin is all- trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine. str-clinda str-treti
How to use
Clindamycin phosphate and tretinoin gel should be applied once daily in the evening, gently rubbing the medication to lightly cover the entire affected area. Approximately a pea-sized amount will be needed for each application. Avoid the eyes, lips, and mucous membranes. Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use. Apply a pea-size amount once daily in the evening lightly covering the entire affected area. Avoid the eyes, lips, and mucous membranes. (2) Not for oral, ophthalmic, or intravaginal use. (2)
Side effects
Observed local treatment-related adverse reactions (≥ 1%) in clinical studies with clindamycin phosphate and tretinoin gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported. (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 Adverse Reactions in Clinical Studies Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared with rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The safety data reflect exposure to clindamycin phosphate and tretinoin gel in 1,104 patients with acne vulgaris. Patients were 12 years and older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥1% of patients treated with clindamycin phosphate and tretinoin gel are presented in Table 1 . Table 1. Treatment-Related Adverse Reactions Reported by ≥1% of Subjects Clindamycin Phosphate and Tretinoin Gel N = 1,104 n (%) Clindamycin Gel N = 1,091 n (%) Tretinoin Gel N = 1,084 n (%) Vehicle Gel N = 552 n (%) Patients with at least one adverse reaction 140 (13) 38 (3) 141 (13) 17 (3) Application site dryness 64 (6) 12…
Warnings
Important safety information
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 tretinoin gel should be discontinued if significant diarrhea occurs. (5.1) Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. (5.2) 5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, clindamycin phosphate and tretinoin gel should be discontinued. Severe colitis has occurred following oral or 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 a 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 Exposure to sunlight, including sunlamps, should be avoided during the use of clindamycin phosphate and tretinoin gel. Patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with clindamycin phosphate and tretinoin gel.
Who should not take Clindamycin Phosphate and Tretinoin
Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic- associated colitis. (4)
Interactions
Clindamycin phosphate and tretinoin gel should not be used in combination with erythromycin-containing products because of its clindamycin component. (7.1) 7.1 Erythromycin Clindamycin phosphate and tretinoin gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component. In-vitro studies have shown antagonism between these 2 antimicrobials. 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 tretinoin gel should be used with caution in patients receiving such agents.
How long does Clindamycin Phosphate and Tretinoin stay in your body?
The elimination half-life of clindamycin phosphate and tretinoin 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
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- How much does Clindamycin Phosphate and Tretinoin 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 $0.18 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 Tretinoin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Clindamycin Phosphate and Tretinoin. To pay less, Clindamycin Phosphate and Tretinoin 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 Tretinoin?
- Clindamycin Phosphate and Tretinoin is marketed by Encube. You can see Encube's full profile, rating, and other products on pharmaranks.
- Is Clindamycin Phosphate and Tretinoin a brand-name or generic drug?
- Clindamycin Phosphate and Tretinoin is a generic medication; its active ingredient is Clindamycin Phosphate and Tretinoin. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Clindamycin Phosphate and Tretinoin available over the counter?
- No. Clindamycin Phosphate and Tretinoin 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 Tretinoin come in?
- Clindamycin Phosphate and Tretinoin is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Clindamycin Phosphate and Tretinoin FDA-registered?
- Clindamycin Phosphate and Tretinoin is on record with the U.S. FDA under application number ANDA216943. You can verify this on its official FDA label.
- Is Clindamycin Phosphate and Tretinoin safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Clindamycin Phosphate and Tretinoin. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Clindamycin Phosphate and Tretinoin?
- Clindamycin Phosphate and Tretinoin's side effects are taken directly from its FDA label. From the label: Observed local treatment-related adverse reactions (≥ 1%) in clinical studies with clindamycin phosphate and tretinoin gel were application site reactions, including dryness, irritation, exfoliation, erythema, pruritus, and dermatitis. Sunburn was also reported.… 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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