Clindamycin Phoaphate Topical Solution USP, 1% Clindamycin Phosphate 10 mg/mL Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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
Where does this data come from?
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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.
-
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.
-
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.
-
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
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 | $0.149 | $8.92 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2966 | $17.80 / 60 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 Phoaphate Topical Solution USP, 1% 10 mg/mLthis 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 | +24% |
| Clindamycin Phosphate 10 mg/mL 45802-0562-01 | Padagis | 1 bottle | $0.184 | AT | Availability likely | +24% |
| Clindamycin Phosphate 10 mg/mL 51672-4081-03 | Sun | 1 bottle | $0.184 | AT | Availability likely | +24% |
| Clindamycin Phosphate 10 mg/mL 72578-0084-02 | Viona | 1 bottle | $0.184 | AT | Availability likely | +24% |
| Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL 72603-0321-01 | Northstar | 1 bottle | $0.184 | AT | Availability likely | +24% |
| 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/mL 62135-0478-30 | Chartwell | 30 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 | — |
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
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 21922-0002-01 You're viewing this | 1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLE | $0.1487 / mL | $8.92 | 2019-03-04 | Active |
| 21922-0002-21 | 1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLE | $0.1843 / mL | $5.53 | 2020-07-13 | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.1487 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 88% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 21922-0002-01?
What NDC number is used to bill for this package of Clindamycin Phoaphate Topical Solution USP, 1% Clindamycin Phosphate 10 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin phosphate topical solution USP, 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 USP, 1% twice daily to affected area. Keep container tightly closed.
⛔ Contraindications ▾
CONTRAINDICATIONS Clindamycin phosphate topical solution USP, 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 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 Events Treatment Emergent Adverse Event Solution n = 553(%) Gel n=148 (%) Lotion n=160(%) Burning 62 (11) 15 (10) 17 (11) Itching 36 (7) 15 (10) 17 (11) Burning/Itching 60 (11) # (-) # (-) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 (7) 22 (14) Oiliness/Oily Skin 8 (1) 26 (18) 12*(10) Peeling 61 (11) # (-) 11 (7) # not recorded * of 126 subjects 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.
🔄 Drug Interactions ▾
Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
🤰 Pregnancy ▾
Pregnancy Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies for clindamycin phosphate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Topically applied clindamycin phosphate topical solution USP, 1% 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% containing clindamycin phosphate equivalent to 10 mg clindamycin per millilitre is available in the following size: 60 mL Bottle – NDC – 21922-002-01 30 mL Bottle – NDC – 21922-002-21 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. 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.
Rx only Manufactured By: Encube Ethicals Pvt. Ltd. Plot No.
C-1, Madkaim Industrial Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Distributed By: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev:10 January 2024
📋 Description ▾
DESCRIPTION Clindamycin phosphate topical solution USP, 1% contain 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). Strucutre Clinda