Clindamycin Phosphate 10 mg/mL Solution, 60 mL
Other active recalls for Clindamycin Phosphate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
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🏭 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.
💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3076 | $18.46 / 60 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL 21922-0002-01 | Encube | 1 bottle | $0.149 | AT | Availability likely | — |
| clindamycin phosphate 10 mg/mL 00168-0201-30 | E. | 1 bottle | $0.184 | AT | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 45802-0562-01 | Padagis | 1 bottle | $0.184 | AT | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 51672-4081-03 | Sun | 1 bottle | $0.184 | AT | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 72578-0084-02 | Viona | 1 bottle | $0.184 | AT | Availability likely | — |
| Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL 72603-0321-01 | Northstar | 1 bottle | $0.184 | AT | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 45802-0263-37 | Padagis | 60 applicators | $0.284 | AT | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 16571-0256-60 | Rising | 60 applicators | $0.284 | AT | Availability likely | — |
| Clindacin P 10 mg/mL 43538-0170-69 | Eurofarma, | 69 applicators | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 50090-2611-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 11.9 mg/mL 50090-5779-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phoaphate Topical USP, 1% 10 mg/mL 50090-6592-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 50090-6593-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mLthis 62135-0478-60 | Chartwell | 60 ml | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 63629-8633-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 63629-8634-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 68788-7990-06 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Clindamycin phosphate 10 mg/mL 70771-1414-02 | Zydus | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 71335-2861-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 71335-2863-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 72162-1418-03 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 50090-1932-00 | A-S | 60 applicators | — | AT | 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?
📊 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 |
|---|---|---|---|
| 62135-0478-30 | 30 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-30) | 2025-08-28 | Active |
| 62135-0478-60 You're viewing this | 60 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-60) | 2025-08-28 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 62135-0478-60?
What is the difference between NDC 62135-0478-60 and NDC 62135-0478-30?
What NDC number is used to bill for this package of Clindamycin Phosphate 10 mg/mL Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution, 1% is indicated 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 topical solution, 1% twice daily to affected area. Keep all liquid dosage forms in containers tightly closed.
⛔ Contraindications ▾
CONTRAINDICATIONS Clindamycin phosphate topical solution, 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. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.
Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. 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 18 clinical studies of various formulations of clindamycin phosphate topical solution using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Number of Patients Reporting Event Treatment Emergent Adverse Event Solution n=553 (%) Burning 62 (11) Itching 36 (7) Burning/Itching 60 (11) Dryness 105 (19) Erythema 86 (16) Oiliness/Oily Skin 8 (1) Peeling 61 (11) 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, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.
🆘 Overdosage ▾
OVERDOSAGE Topically applied clindamycin phosphate topical solution can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.
Microbiology Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Antimicrobial Activity Clindamycin is active in vitro against most isolates of Propionibacterium acnes ; however, the clinical significance is unknown.
Resistance Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B.
Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clindamycin Phosphate Topical Solution, USP, 1% is clear, colorless solution free of foreign matter and crystallized particles containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 30 mL applicator bottle - NDC – 62135-478-30 60 mL applicator bottle - NDC – 62135-478-60 Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP]. Protect from freezing. Rx only To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Chartwell RX, LLC. at 1-845-232-1683.
Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L72665 Rev. 08/2025
📋 Description ▾
DESCRIPTION Clindamycin Phosphate Topical Solution, USP contains Clindamycin Phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide, and purified water.
The structural formula is 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 -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). "Image Description"