Clindamycin Phosphate

INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Topical Lotion are 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 & ADMINISTRATION 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.

CONTRAINDICATIONS Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Topical Lotion are 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.

ADVERSE REACTIONS In 18 clinical studies of various formulations of clindamycin 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. To report SUSPECTED ADVERSE REACTIONS, contact Carnegie Pharmaceuticals, LLC at 1-732-783-7010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown.

DESCRIPTION Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. 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, and purified water. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: Molecular Formula: C 18 H 34 ClN 2 O 8 PS 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). chemical-structure

OVERDOSAGE Topically applied Clindamycin Phosphate Topical Solution USP, 1% can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).

HOW SUPPLIED 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