Clindamycin phosphate topical solution USP For External Use Rx only

Clindamycin phosphate topical solution USP contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each clindamycin phosphate topical solution USP pledget applicator contains approximately 1 mL of topical solution.


Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.


The solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 to 7.0).


The structural formula is represented below:

clindamycin-structure.jpg

Molecular formula: C₁₈H₃₄ClN₂O₈PS

Molecular weight: 504.97


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).

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.

Clindamycin phosphate topical solution 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).

Clindamycin phosphate topical solution 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.

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 systemic absorption 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 Clostridioides 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 Clostridioides  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.

In 18 clinical studies of various formulations of topical 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]. 

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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.

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Topically applied clindamycin phosphate topical solution can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Do not use if the seal on jar is broken. Use a clindamycin phosphate topical solution, 1% pledget for the application of clindamycin phosphate topical solution, 1% twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.

Clindamycin phosphate topical solution is flammable. Avoid fire, flame, and smoking during and immediately following application.

Pledget: Remove pledget from jar just before use. Discard after single use. 


Keep jar tightly closed.

Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available as follows: Jar containing white round stack of pledgets moistened with solution. Each pledget is a white, round with diamond dot patterns moistened with solution.


A jar containing 60 single-use pledget applicators (NDC 16571-256-60)
A jar containing 69 single-use pledget applicators (NDC 16571-256-69)


Store at 20°C to 25°C (68°F to 77°F); excursion permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

Protect from freezing.

Clindamycin phosphate topical solution is flammable. Keep away from heat, sparks or open flames.


Manufactured for:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816


Made in India


Neutral Code: 4323147/TS/DRUGS/2025


Revised: 03/2026


PIR25669-03

NDC 16571-256-60

Clindamycin Phosphate Topical Solution, USP 1%* (Pledgets)

Pledgets for topical use only

60 Pledgets

Rx only

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