Clindamycin Phosphate 1 g/10mL Gel
Other active recalls for Clindamycin Phosphate (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria that cause acne and by decreasing swelling.
Read the full MedlinePlus article ↗- Clindamycin is used for serious bacterial infections — things like deep skin infections, lung abscesses, pelvic infections, and abdominal infections. It's often chosen when penicil...
- What kinds of infections is clindamycin actually used for?
- You don't have to eat with it — food doesn't meaningfully change how it's absorbed. But the most important thing is to take each capsule with a full, large glass of water, and stay...
- Do I need to take clindamycin with food?
Patient education
Supplement & herbal interactions
Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.481 | $261.08 / 75 ml |
| Medicaid paysCMS SDUD · 12 mo | $6.61 | $495.39 / 75 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clindamycin Phosphate 1 g/100mL 69238-2031-07 | Amneal | 1 bottle | $3.481 | AB2 | Availability likely | — |
| Clindamycin Phosphate 1 g/10mLthis 73473-0302-75 | Solaris | 1 bottle | $3.481 | AB2 | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 68682-0462-75 | Oceanside | 1 bottle | $5.280 | AB2 | FDA listed | +52% |
| Clindagel 10 mg/mL 16781-0462-06 | Bausch | 6 bottles | — | AB2 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73473-0302-75 You're viewing this | 1 BOTTLE in 1 CARTON (73473-302-75) / 75 mL in 1 BOTTLE | 2021-08-14 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin phosphate gel, 1% is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS , WARNINGS , and ADVERSE REACTIONS .)
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin film of clindamycin phosphate gel USP, 1% once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly. Keep container tightly closed.
⛔ Contraindications ▾
CONTRAINDICATIONS Clindamycin phosphate gel, 1% is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
⚠️ Warnings ▾
WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
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. Endoscopic examination may reveal pseudomembranous colitis.
Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.
Antiperistaltic agents, such as opiates and diphenoxylate with atropine, may prolong and/or worsen the condition. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In the one well-controlled clinical study comparing clindamycin phosphate and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented below: Number (%) of Patients Body System/Adverse Event Clindamycin Phosphate QD N=168 Vehicle Gel QD N=84 Skin and appendages disorders Dermatitis 0 (0.0) 1 (1.2) Dermatitis contact 0 (0.0) 1 (1.2) Dermatitis fungal 0 (0.0) 1 (1.2) Folliculitis 0 (0.0) 1 (1.2) Photosensitivity reaction 0 (0.0) 1 (1.2) Pruritus 1 (0.6) 1 (1.2) Rash erythematous 0 (0.0) 0 (0.0) Skin dry 0 (0.0) 0 (0.0) Peeling 1 (0.6) 0 (0.0) Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.
Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ). Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE Topically applied clindamycin phosphate may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics: In an open-label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3 to 12 grams/day of clindamycin phosphate for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL. Following multiple applications of clindamycin phosphate less than 0.04% of the total dose was excreted in the urine. Microbiology: Although clindamycin phosphate is inactive in vitro , rapid in vitro hydrolysis converts this compound to clindamycin, which has antibacterial activity.
Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 mcg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size: 75 mL bottle - NDC 73473-302-75 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Do not store in direct sunlight. Manufactured for: Solaris Pharma Corporation Bridgewater, NJ 08807,USA Revised 08/2021
📋 Description ▾
DESCRIPTION Clindamycin phosphate gel USP, 1%, a topical antibiotic, contains clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 981, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below: 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). structure