HomeNDC LookupIngredientsClindamycin Phosphate › 51672-1399-02
Clindamycin Phosphate 10 mg/g Gel — NDC 51672-1399-02 package photo

Clindamycin Phosphate 10 mg/g Gel

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-1399-2) / 30 g in 1 TUBE
NDC 51672-1399-02
🏷️ FDA NDC (as labeled) 51672-1399-2 billing pads the package segment with a zero
This package
Contains30 g in 1 tube Cost per g$0.1394 NADAC Per package$4.18 / 30 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.4340/unit · Part D plans $0.3596/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 →
⚠️
Other active recalls for Clindamycin Phosphate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0815-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0808-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0817-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0818-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0816-2026
Class III · Nov 26, 2025 — Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0257-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51672-1399-2
Product NDC 51672-1399
11-digit billing NDC 51672139902
NCPDP billing unit GM — per gram (weight)
RxCUI 2676585
UNII EH6D7113I8
UPC 0351672139926
Application # ANDA214052
SPL Set ID 80c40d1a-2541-4164-8ccb-1b512a851734
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 2020-11-10
Route TOPICAL
Dosage form GEL
Substance CLINDAMYCIN PHOSPHATE
GPI-14 90051010104007
GPI class Clindamycin Phosphate
GCN Seq No 007726
GCN 45410
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 PH 1% GEL
FDB brand name Clindamycin Phosphate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 51672-1399-2 — a 5-4-1 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 package segment → 51672-1399-02. 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA214052 (ANDA)
Labeler code51672
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio889 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 PH 1% GEL Ingredient Clindamycin Phosphate
📖 What it is MedlinePlus · NLM

Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria that cause acne and by decreasing swelling.

Read the full MedlinePlus article ↗
📗 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 →
7
Nutrient depletion considerations

Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.

7 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 gPer package
Retail pharmacies payNADAC · weekly $0.139 $4.18 / 30 g
Medicaid paysCMS SDUD · 12 mo $0.4340 $13.02 / 30 g
Medicare drug plans payPart D · Q2 2026 $0.3596 $10.79 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.753 $0.137
▼ Down 80% over the last 24 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/g 00168-0202-30 E. 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 16714-0161-01 NORTHSTAR 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 21922-0027-05 Encube 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 45802-0900-94 Padagis 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/gthis 51672-1399-02 Sun 1 tube $0.139 AB1 Availability likely
clindamycin phosphate 10 mg/g 59762-3743-01 Mylan 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 62332-0623-30 Alembic 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 68462-0866-35 GLENMARK 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 72578-0118-01 Viona 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 73473-0300-30 Solaris 1 tube $0.139 AB1 Availability likely
Clindamycin Phosphate 10 mg/g 46708-0623-30 Alembic 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 50090-5958-00 A-S 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 50090-6072-00 A-S 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 59651-0806-30 Aurobindo 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 63629-8630-01 Bryant 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 63629-8631-01 Bryant 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 63629-9309-01 Bryant 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 68788-8423-06 Preferred 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 70771-1855-02 Zydus 1 tube AB1 FDA listed
Clindamycin Phosphate 10 mg/g 72162-1436-06 Bryant 1 tube AB1 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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 years 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 51672-1399-02, 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.
📅 Q1 2025 – Q4 2025 · 4 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
1.2K
Units reimbursed last 4 qtrs
47.7K
Gross reimbursed last 4 qtrs
$20.7K
Avg / prescription
$16.70
Avg / unit
$0.4340
Latest quarter Q4 2025
308Rx
Medicaid pays / g
$0.4340
gross reimbursed
vs
NADAC / g
$0.1394
acquisition cost
=
Spread
+$0.2946
+211% vs cost
What Medicaid paid per g (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
95% FFS
Fee-for-service · 1,174 Rx Managed care · 65 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,800 units · 30.5 per 100k residents WI Michigan: no data reported MI New York: 32,280 units · 165 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 480 units · 3.7 per 100k residents PA New Jersey: 480 units · 5.2 per 100k residents NJ Massachusetts: no data reported MA California: 11,130 units · 28.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 630 units · 8.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 870 units · 3.8 per 100k residents FL
Units reimbursed · per 100k residents
3.7165
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 York 165 /100k
2 Wisconsin 30.5 /100k
3 California 28.6 /100k
4 Arizona 8.5 /100k
5 New Jersey 5.2 /100k
6 Florida 3.8 /100k
7 Pennsylvania 3.7 /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.
1 tube51672-1399-03 2,879 Rx · $56,174
1 tube this page51672-1399-02 1,045 Rx · $17,492
1 tube51672-1399-07 No Medicaid data
Drug total (last 4 qtrs): 3,924 Rx · 213,200 units · $73,666 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 — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity2,885
Diarrhoea2,242
Rash2,049
Nausea1,961
Pain1,787
Fatigue1,548
Acute Kidney Injury1,428

Age at onset

Neonate149
Infant54
Child118
Adolescent224
Adult2,915
Elderly1,318

Reporter sex

33,708 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization12,220
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,867 898
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
51672-1399-02 You're viewing this 1 TUBE in 1 CARTON (51672-1399-2) / 30 g in 1 TUBE $0.1394 / g $4.18 2020-11-10 Active
51672-1399-03 1 TUBE in 1 CARTON (51672-1399-3) / 60 g in 1 TUBE $0.1320 / g $7.92 2020-11-10 Active
51672-1399-07 1 TUBE in 1 CARTON (51672-1399-7) / 75 g in 1 TUBE 2024-10-30 Active

Per g, this pack runs about 6% above the cheapest pack (NDC 51672-1399-03, $0.1320 vs $0.1394 NADAC).

This pack accounts for about 27% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-1399-02?
NDC 51672-1399-02 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Clindamycin Phosphate 10 mg/g Gel?
Bill NDC 51672-1399-02 — the 11-digit billing format is 51672139902. 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 46 words

INDICATIONS AND USAGE Clindamycin phosphate gel 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 22 words

DOSAGE AND ADMINISTRATION Apply a thin film of clindamycin phosphate gel USP, 1% twice daily to affected area. Keep container tightly closed.

Contraindications 33 words

CONTRAINDICATIONS Clindamycin phosphate gel 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 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) not recorded ( – ) ( – ) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 ( 7) 22 (14) Oiliness/Oily Skin 8 ( 1) 26 (18) 12 of 126 subjects (10) Peeling 61 (11) ( – ) 11 ( 7) 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 Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 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 44 words

Geriatric Use Clinical studies for clindamycin phosphate gel 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 18 words

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

🧬 Clinical Pharmacology 185 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 to 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 57 words

HOW SUPPLIED 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 51672-1399-2 60 gram tube - NDC 51672-1399-3 75 gram tube - NDC 51672-1399-7 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

📦 Storage and Handling 16 words

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

📋 Description 89 words

DESCRIPTION Clindamycin phosphate gel USP, 1% 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 gel contains allantoin, carbomer homopolymer type B, methylparaben, polyethylene glycol 400, propylene glycol, purified water and sodium hydroxide.

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). Chemical Structure

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.