Clindamycin Phosphate
10 mg/mL · Solution
- Prescription only
- Lincosamide Antibacterial
- Active substance
- Clindamycin Phosphate
- Made by
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-01-28
Not necessarily this product — shortages are reported per presentation. Your pharmacy will know. · Updated 2026-09-21 FDA drug shortages
Lincosamide Antibacterial
- Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Topical Lotion are indicated in the treatment of acne vulgaris.
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…
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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 ).
From the official label · 2026-01-28 · DailyMed
How it works
From this product’s own US prescribing label.
The mechanism of action of clindamycin in treating acne vulgaris is unknown.
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 to 3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-28
Do not take it if
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.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Apply a thin film of, Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Topical Lotion, or Clindamycin Phosphate Gel twice daily to affected area.
- Clindamycin Phosphate Topical Solution is flammable.
- Avoid fire, flame, and smoking during and immediately following application.
- Lotion: Shake well immediately before using.
- Keep all liquid dosage forms in containers tightly closed.
Quoted from the official label, section “Dosage & Administration”.
Other 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 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.
- General Clindamycin Phosphate Topical Solution contains an alcohol base which will cause burning and irritation of the eye.
- In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water.
- The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.
- Clindamycin Phosphate should be prescribed with caution in atopic individuals.
- Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
- 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.
- Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of Clindamycin Phosphate.
- Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.
- Geriatric Use Clinical studies for topical Clindamycin products did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- General Clindamycin Phosphate Topical Solution contains an alcohol base which will cause burning and irritation of the eye.
- In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water.
- The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.
- Clindamycin Phosphate should be prescribed with caution in atopic individuals.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- It is not known whether clindamycin is excreted in breast milk following use of Clindamycin Phosphate.
- However, orally and parenterally administered clindamycin has been reported to appear in breast milk.
- Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora.
- Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.
- Clinical Considerations If used during lactation and Clindamycin Phosphate is applied to the chest, care should be taken to
- avoid accidental ingestion by the infant.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
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.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
Topically applied Clindamycin Phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).
Quoted from the official label, section “Overdosage”.
Use in children
Safety and effectiveness in pediatric patients under the age of 12 have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Clinical studies for topical Clindamycin products 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.
Quoted from the official label, section “Geriatric Use”.
Side effects
- 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 Gel Lotion n=553 (%) n=148 (%) 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.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Clindamycin Phosphate Topical Solution, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:
- 30 mL applicator bottle NDC 0168-0201-30 60 mL applicator bottle NDC 0168-0201-60 Clindamycin Phosphate Gel, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:
- 30 gram tube NDC 0168-0202-30 60 gram tube NDC 0168-0202-60 Clindamycin Phosphate Topical Lotion, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:
- 60 mL bottle NDC 0168-0203-60
- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- Protect from freezing.
- E.
- FOUGERA & CO.
- A division of Fougera Pharmaceuticals Inc.
- MELVILLE, NEW YORK 11747 Rev. 11/2025
Quoted from the official label, section “How Supplied”.
What is in it
- 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
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (13)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 13 of 13
- Clindamycin PhosphateThis onePrescription onlyE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyCarnegie Pharmaceuticals, LLCNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyChartwell RX, LLCNo ingredient list on the stored label
- Clindacin PPrescription onlyEurofarma, Inc.No ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyi3 Pharmaceuticals, LLCNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyPadagis Israel Pharmaceuticals LtdNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyPreferred Pharmaceuticals IncNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyRising Pharma Holdings, Inc.No ingredient list on the stored label
- Clindamycin PhosphatePrescription onlySun Pharmaceutical Industries, Inc.No ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyViona Pharmaceuticals IncNo ingredient list on the stored label
- Clindamycin PhosphatePrescription onlyZydus Lifesciences LimitedNo ingredient list on the stored label
Details
| Made by | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
|---|---|
| Active substance | Clindamycin Phosphate |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 10 mg/mL |
| Form | Solution |
| Route | Topical |
| Packs | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE · 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE |
| NDC | 0168-0201 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
50 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Gel19 products
- Solution13 products
10 mg/mL12
10 mg/mL · 12 companies
- A-S Medication Solutions
- Bryant Ranch Prepack
- Carnegie Pharmaceuticals, LLC
- Chartwell RX, LLC
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · this page
- i3 Pharmaceuticals, LLC
- Padagis Israel Pharmaceuticals Ltd
- Preferred Pharmaceuticals Inc
- 11.9 mg/mL
- Lotion7 products
10 ug/mL2
10 ug/mL · 2 companies
- Injection, Solution5 products
- 300 mg/50mL
600 mg/50mL2
600 mg/50mL · 2 companies
900 mg/50mL2
900 mg/50mL · 2 companies
Show all forms · 6 forms
- Aerosol, Foam4 products
- Cream2 products
20 mg/g2
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.