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Clindamycin Phosphate 10 mg/mL Solution, 60 applicators

by Carnegie Pharmaceuticals, LLC · 60 APPLICATOR in 1 JAR (80005-131-09) / 1 mL in 1 APPLICATOR
NDC 80005-0131-09
🏷️ FDA NDC (as labeled) 80005-131-09 billing pads the product segment with a zero
This package
Contains60 applicators Cost per ea$0.2840 NADAC Per package$17.04 / 60 applicators Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4189/unit · Part D plans $0.3076/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 80005-131-09
Product NDC 80005-131
11-digit billing NDC 80005013109
NCPDP billing unit EA — each (per item)
RxCUI 309333
UNII EH6D7113I8
Application # ANDA219612
SPL Set ID c8fe61f1-f3c5-4452-9980-a727461b9844
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-16
Route TOPICAL
Dosage form SOLUTION
Substance CLINDAMYCIN PHOSPHATE
GPI-14 90051010109420
GCN Seq No 022140
GCN 45411
HICL code 004045
Ingredient (HICL) Clindamycin Phosphate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5W
Therapeutic class — specific (HIC3) Topical Antibiotics
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLINDAMYCIN PHOS 1% PLEDGET
FDB brand name Clindamycin Phosphate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 80005-131-09 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 80005-0131-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Lincosamide Antibacterial class.

Pharmacologic class Lincosamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Antibiotics, Lincosamides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCarnegie Pharmaceuticals, LLC
Application holderCARNEGIE PHARMACEUTICALS LLC
FDA applicationANDA219612 (ANDA)
Labeler code80005
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio5 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CLINDAMYCIN PHOS 1% PLEDGET Ingredient Clindamycin Phosphate
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Clindamycin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.284 $17.04 / 60 applicators
Medicaid paysCMS SDUD · 12 mo $0.4189 $25.13 / 60 applicators
Medicare drug plans payPart D · Q2 2026 $0.3076 $18.46 / 60 applicators
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.294 $0.278
Flat over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin Phosphate 10 mg/mL 16571-0256-60 Rising 60 applicators $0.284 AT Availability likely
Clindamycin Phosphate 10 mg/mL 45802-0263-37 Padagis 60 applicators $0.284 AT Availability likely
Clindamycin phosphate 10 mg/mL 72319-0696-60 i3 60 applicators $0.284 AT Availability likely
Clindamycin Phosphate 10 mg/mLthis 80005-0131-09 Carnegie 60 applicators $0.284 AT Availability likely
Clindacin P 10 mg/mL 43538-0170-69 Eurofarma, 69 applicators AT FDA listed
Clindacin ETZ 10 mg 43538-0172-60 Eurofarma, 60 packets AT FDA listed
Clindamycin Phosphate 10 mg/mL 50090-1932-00 A-S 60 applicators AT FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 80005-0131-09, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q4 2025 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
10.4K
Units reimbursed last 4 qtrs
631.1K
Gross reimbursed last 4 qtrs
$264.3K
Avg / prescription
$25.52
Avg / unit
$0.4189
Latest quarter Q4 2025
7.2KRx
Medicaid pays / ea
$0.4189
gross reimbursed
vs
NADAC / ea
$0.2840
acquisition cost
=
Spread
+$0.1349
+48% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
20% FFS 80% MCO
Fee-for-service · 2,061 Rx Managed care · 8,297 Rx
State Medicaid map
Alaska: no data reported AK Maine: 780 units · 55.9 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,980 units · 86.8 per 100k residents MN Wisconsin: no data reported WI Michigan: 97,440 units · 971 per 100k residents MI New York: 22,110 units · 113 per 100k residents NY Vermont: 840 units · 130 per 100k residents VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 1,620 units · 50.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 660 units · 20.6 per 100k residents IA Illinois: 16,380 units · 131 per 100k residents IL Indiana: 2,820 units · 41.1 per 100k residents IN Ohio: 3,660 units · 31.1 per 100k residents OH Pennsylvania: 14,760 units · 114 per 100k residents PA New Jersey: 127,140 units · 1,369 per 100k residents NJ Massachusetts: 1,680 units · 24.0 per 100k residents MA California: 18,180 units · 46.7 per 100k residents CA Utah: no data reported UT Colorado: 13,020 units · 222 per 100k residents CO Nebraska: 2,220 units · 112 per 100k residents NE Missouri: 7,140 units · 115 per 100k residents MO Kentucky: 14,040 units · 310 per 100k residents KY West Virginia: 12,840 units · 725 per 100k residents WV Virginia: 14,880 units · 171 per 100k residents VA Maryland: 11,760 units · 190 per 100k residents MD Connecticut: 11,160 units · 309 per 100k residents CT Rhode Island: 8,400 units · 767 per 100k residents RI Arizona: 7,080 units · 95.3 per 100k residents AZ New Mexico: no data reported NM Kansas: 4,380 units · 149 per 100k residents KS Arkansas: no data reported AR Tennessee: 27,240 units · 382 per 100k residents TN North Carolina: 74,400 units · 687 per 100k residents NC South Carolina: no data reported SC Delaware: 1,500 units · 145 per 100k residents DE Oklahoma: 4,140 units · 102 per 100k residents OK Louisiana: 34,350 units · 751 per 100k residents LA Mississippi: 10,080 units · 343 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,320 units · 4.3 per 100k residents TX Florida: 58,080 units · 257 per 100k residents FL
Units reimbursed · per 100k residents
4.31,369
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 1,369 /100k
2 Michigan 971 /100k
3 Rhode Island 767 /100k
4 Louisiana 751 /100k
5 West Virginia 725 /100k
6 North Carolina 687 /100k
7 Tennessee 382 /100k
8 Mississippi 343 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 10,358 Rx · 631,080 units · $264,336 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clindamycin Phosphate — the program that covers self-administered drugs. 16 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clindamycin Phosphate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.9M
Claims incl. refills
181.3K
Beneficiaries
134.5K
Spend / beneficiary
$51.31
Spend / claim
$38.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Clindamycin Phosphate (this brand).

Top reported reactions

Rash251
Drug Hypersensitivity228
Diarrhoea187
Nausea180
Fatigue166
Pain158
Pruritus157

Age at onset

Neonate11
Infant5
Child12
Adolescent40
Adult320
Elderly114

Reporter sex

3,459 reports
Male · 35%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,027
Death263
Disabling72
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 307 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
80005-0131-09 You're viewing this 60 APPLICATOR in 1 JAR (80005-131-09) / 1 mL in 1 APPLICATOR $0.2840 / ea $17.04 2025-06-16 Active
80005-0131-38 69 APPLICATOR in 1 JAR (80005-131-38) / 1 mL in 1 APPLICATOR 2025-12-15 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 80005-0131-09?
NDC 80005-0131-09 contains 60 applicators — 60 applicator in 1 jar / 1 ml in 1 applicator.
What is the difference between NDC 80005-0131-09 and NDC 80005-0131-38?
Both are Clindamycin Phosphate 10 mg/mL Solution — the drug itself is identical. NDC 80005-0131-09 is the 60 applicators package, while NDC 80005-0131-38 is the 69 applicators package.
What NDC number is used to bill for this package of Clindamycin Phosphate 10 mg/mL Solution?
Bill NDC 80005-0131-09 — the 11-digit billing format is 80005013109. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 45 words

INDICATIONS AND USAGE 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 ).

⏱️ Dosage and Administration 78 words

DOSAGE AND ADMINISTRATION Use a Clindamycin Phosphate Topical Solution pledget for the application of Clindamycin Phosphate Topical Solution 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: Do not use if the seal is broken.

Discard after single use. Keep the jar tightly closed after each use.

Contraindications 34 words

CONTRAINDICATIONS 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.

⚠️ Warnings ~1 min read

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.

🤒 Adverse Reactions 205 words

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 33 words

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 59 words

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 17 words

Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.

🧓 Geriatric Use 42 words

Geriatric Use Clinical studies for clindamycin 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 17 words

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

🧬 Clinical Pharmacology 183 words

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.

🧬 Mechanism of Action 15 words

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

📦 How Supplied / Storage and Handling 80 words

HOW SUPPLIED Clindamycin Phosphate Topical Solution, USP containing clindamycin phosphate, USP equivalent to 10 mg clindamycin per milliliter is available in a jar containing 60 single-use pledget applicators (NDC 80005-131-09) and a jar containing 69 single-use pledget applicators (NDC 80005-131-38). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from freezing.

Clindamycin Phosphate Topical Solution, USP is flammable. Keep away from heat, sparks or open flames.

📋 Description 99 words

DESCRIPTION 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, sodium hydroxide pellets, and 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). structural formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.