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Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g Gel — NDC 63629-8635-01 package photo
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Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g Gel — NDC 63629-8635-1 (Billing 63629-8635-01)

by Bryant Ranch Prepack · 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP

This is a package of Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g Gel from Bryant Ranch Prepack, marketed since Sep 2019 and currently FDA-listed. It is this product's only package size.

NDC 63629-8635-01
🏷️ FDA NDC (as labeled) 63629-8635-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63629-8635-1
Product NDC 63629-8635
11-digit billing NDC 63629863501
NCPDP billing unit GM — per gram (weight)
UNII W9WZN9A0GM, EH6D7113I8
Application # ANDA205397
SPL Set ID ac7f5c47-a06a-495f-a914-13c930106c8d
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 2019-09-12
Route TOPICAL
Dosage form GEL
Substance BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 066978
GCN 29418
HICL code 017263
Ingredient (HICL) Clindamycin Phos/Benzoyl Perox
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLIND PH-BENZOYL PERO 1.2-2.5%
FDB brand name Clindamycin Phos-Benzoyl Perox
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066978
  • GCN: 29418
  • HICL (First Databank): 017263
  • AHFS class code: 08:12.28.20
Why two NDCs? The FDA registers this code as 63629-8635-1 — 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 → 63629-8635-01. 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.

Clinical

Label name CLIND PH-BENZOYL PERO 1.2-2.5% Ingredient Clindamycin Phos/Benzoyl Perox

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63629-8635-01 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP 2019-09-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin phosphate and benzoyl peroxide 25 mg/g; 10 mg/g 00591-3916-68 Actavis 1 bottle $0.767 — Discontinued —
Clindamycin Phosphate And Benzoyl Peroxide 10 mg/g; 25 mg/g 21922-0074-40 Encube 1 bottle $0.819 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g 45802-0597-01 Padagis 1 bottle $0.819 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/g 51672-1367-03 Sun 1 bottle $0.819 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/g 68682-0132-50 Oceanside 1 bottle $1.330 AB FDA listed —
Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/gthis 63629-8635-01 Bryant 1 bottle — AB FDA listed —
Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g 72162-2077-01 Bryant 1 bottle — AB 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA205397 (ANDA)
Labeler code63629
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio4,436 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

⏱️ Dosage and Administration 142 words ▾

2 DOSAGE AND ADMINISTRATION Before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin.

Use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% beyond 12 weeks has not been evaluated. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is not for oral, ophthalmic, or intravaginal use.

Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the face once daily. (2) Not for oral, ophthalmic, or intravaginal use. (2)

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 1.2%/2.5% Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel. Gel, 1.2% clindamycin phosphate/2.5% benzoyl peroxide

⛔ Contraindications 135 words ▾

4 CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in: Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4.1) Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. (4.2)

4.1Hypersensitivity Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%. [ See Postmarketing Experience (6.2) . ]

4.2Colitis/Enteritis Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. [ See Warnings and Precautions (5.1) . ]

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Colitis: Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should be discontinued if significant diarrhea occurs.

(5.1) Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. (5.2)

5.1Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. When significant diarrhea occurs, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate 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. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application.

5.3Concomitant Topical Medications Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of subjects treated with clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).

During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.

Table 1: Percent of Subjects with Local Skin Reactions. Combined Results from the Two Phase 3 Trials (N = 773) Combined Results from the Two Phase 3 Trials (N=773) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod.* Severe Mild Mod.* Severe Mild Mod.* Severe Erythema 22 4 0 25 5 <1 15 2 0 Scaling 8 <1 0 18 3 0 8 1 0 Itching 10 2 0 15 2 0 6 <1 0 Burning 3 <1 0 8 2 0 2 <1 0 Stinging 2 <1 0 6 1 0 1 <1 0 *Mod. = Moderate

6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS Avoid using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in combination with topical or oral erythromycin-containing products because of its clindamycin component. (7.1)

7.1Erythromycin Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

7.2Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should be used with caution in patients receiving such agents.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data) . In limited published 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 major birth defects.

In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times the maximum recommended human dose (MRHD) of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, based on body surface area (BSA) comparisons (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy.

Animal Data Animal reproductive/developmental toxicity studies have not been conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in pregnant rats and mice administered during the period of organogenesis at oral doses of up to 600 mg/kg/day (240 and 120 times the MRHD for clindamycin, respectively, based on BSA comparisons) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the MRHD for clindamycin, respectively, based on BSA comparisons) revealed no malformations or embryo-fetal development toxicity.

8.2Lactation Risk Summary There are no data on the presence of clindamycin or benzoyl peroxide in human milk, the effects on the breastfed child, or the effects on milk production following topical administration. However, clindamycin has been reported to be present in breast milk in small amounts following oral and parenteral administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and any potential adverse effects on the breastfed child from Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% or from the underlying maternal condition.

Clinical Considerations If used during lactation and Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

8.4Pediatric Use Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in pediatric patients under the age of 12 have not been evaluated.

8.5Geriatric Use Clinical trials of clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data) . In limited published 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 major birth defects.

In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times the maximum recommended human dose (MRHD) of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, based on body surface area (BSA) comparisons (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy.

Animal Data Animal reproductive/developmental toxicity studies have not been conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in pregnant rats and mice administered during the period of organogenesis at oral doses of up to 600 mg/kg/day (240 and 120 times the MRHD for clindamycin, respectively, based on BSA comparisons) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the MRHD for clindamycin, respectively, based on BSA comparisons) revealed no malformations or embryo-fetal development toxicity.

🧒 Pediatric Use 26 words ▾

8.4Pediatric Use Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in pediatric patients under the age of 12 have not been evaluated.

🧓 Geriatric Use 33 words ▾

8.5Geriatric Use Clinical trials of clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clindamycin: Clindamycin is a lincosamide antibacterial [ See Microbiology (12.4) ]. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.

12.3Pharmacokinetics The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% applied to the face once daily for 30 days. Twelve subjects (75%) had at least one quantifiable clindamycin plasma concentration above the lower limit of quantification (LOQ = 0.5 ng/mL) on Day 1 or Day 30. On Day 1, the mean (± standard deviation) peak plasma concentration (C max ) was 0.78 ± 0.22 ng/mL (n=9 with measurable concentrations), and the mean AUC 0-t was 5.29 ± 0.81 h.ng/mL (n=4).

On Day 30, the mean C max was 1.22 ± 0.88 ng/mL (n=10), and the mean AUC 0-t was 8.42 ± 6.01 h.ng/mL (n=6). Clindamycin plasma concentrations were below LOQ in all subjects at 24 hours post-dose on the three tested days (Day 1, 15, and 30). Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

12.4Microbiology Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis. Clindamycin and benzoyl peroxide individually have been shown to have in vitro activity against Propionibacterium acnes , an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes is not known. P. acnes resistance to clindamycin has been documented.

Resistance to clindamycin is often associated with resistance to erythromycin.

🧬 Mechanism of Action 36 words ▾

12.1Mechanism of Action Clindamycin: Clindamycin is a lincosamide antibacterial [ See Microbiology (12.4) ]. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a white to off-white smooth gel supplied as: NDC 63629-8635-1 50 g pump

16.2Dispensing Instructions for the Pharmacist Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% with a 10-week expiration date. Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”

16.3Storage and Handling PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2°C to 8°C (36°F to 46°F). PATIENT: Store at room temperature at or below 25°C (77°F). Protect from freezing. Store pump upright. Keep out of the reach of children. Keep container tightly closed.

📋 Description 171 words ▾

11 DESCRIPTION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. 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 - Dgalacto-octopyranoside 2 -(dihydrogen phosphate).

The structural formula or clindamycin phosphate is represented below: Clindamycin phosphate: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below: Benzoyl peroxide: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% contains the following inactive ingredients: purified water, carbomer 980, propylene glycol, and potassium hydroxide.

Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin. structure1 structure2

💬 Information for Patients 103 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.

Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% may bleach hair or colored fabric.

🧬 Pharmacokinetics 171 words ▾

12.3Pharmacokinetics The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% applied to the face once daily for 30 days. Twelve subjects (75%) had at least one quantifiable clindamycin plasma concentration above the lower limit of quantification (LOQ = 0.5 ng/mL) on Day 1 or Day 30. On Day 1, the mean (± standard deviation) peak plasma concentration (C max ) was 0.78 ± 0.22 ng/mL (n=9 with measurable concentrations), and the mean AUC 0-t was 5.29 ± 0.81 h.ng/mL (n=4).

On Day 30, the mean C max was 1.22 ± 0.88 ng/mL (n=10), and the mean AUC 0-t was 8.42 ± 6.01 h.ng/mL (n=6). Clindamycin plasma concentrations were below LOQ in all subjects at 24 hours post-dose on the three tested days (Day 1, 15, and 30). Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of once daily use of clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% were assessed in two 12-week multi-center, randomized, blinded trials in subjects 12 years and older with moderate to severe acne vulgaris. The two trials were identical in design and compared clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% to clindamycin in the vehicle gel, benzoyl peroxide in the vehicle gel, and the vehicle gel alone. The co-primary efficacy variables were: (1) Mean absolute change from baseline at Week 12 in: Inflammatory lesion counts Non-inflammatory lesion counts (2) Percent of subjects who had a 2-grade improvement from baseline on an Evaluator’s Global Severity (EGS) score.

The EGS scoring scale used in all of the clinical trials for clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% is as follows: Grade Description Clear Normal, clear skin with no evidence of acne vulgaris Almost Clear Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) Mild Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions) Moderate Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one small nodulocystic lesion Severe Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulocystic lesions Very Severe Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions The results of Trial 1 at Week 12 are presented in Table 2: Table 2: Trial 1 Results Trial 1 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% N=399 Clindamycin Gel N=408 Benzoyl Peroxide Gel N=408 Vehicle Gel N=201 EGSS Clear or Almost Clear 115 (29%) 84 (21%) 76 (19%) 29 (14%) 2-grade reduction from baseline 131 (33%) 100 (25%) 96 (24%) 38 (19%) Inflammatory Lesions: Mean absolute change 14.8 12.2 13.0

9.0Mean percent (%) reduction 55.0% 47.1% 49.3% 34.5% Non-Inflammatory Lesions: Mean absolute change 22.1 17.9 20.6

13.2Mean percent (%) reduction 45.3% 38.0% 40.2% 28.6% The results of Trial 2 at Week 12 are presented in Table 3: Table 3: Trial 2 Results Trial 2 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% N=398 Clindamycin Gel N=404 Benzoyl Peroxide Gel N=403 Vehicle Gel N=194 EGSS Clear or Almost Clear 113 (28%) 94 (23%) 94 (23%) 21 (11%) 2-grade reduction from baseline 147 (37%) 114 (28%) 114 (28%) 27 (14%) Inflammatory Lesions: Mean absolute change 13.7 11.3 11.2

5.7Mean percent (%) reduction 54.2% 45.3% 45.7% 23.3% Non-Inflammatory Lesions: Mean absolute change 19.0 14.9 15.2

8.3Mean percent (%) reduction 41.2% 34.3% 34.5% 19.2%

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and impairment of fertility testing of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% have not been performed. Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice.

The clinical significance of this is unknown. Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times the MRHD for clindamycin and 3.6, 10.8, and 60 times the MRHD for benzoyl peroxide, respectively, based on BSA comparisons) did not cause any increase in tumors.

However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900, and 3000 mg/kg/day (1.2, 3.6, and 12 times the MRHD for clindamycin and 2.4, 7.2, and 24 times the MRHD for benzoyl peroxide, respectively, based on BSA comparisons) for up to 97 weeks did not cause any increase in tumors.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin.

Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the MRHD for clindamycin, based on BSA comparisons) revealed no effects on fertility or mating ability.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and impairment of fertility testing of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% have not been performed. Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice.

The clinical significance of this is unknown. Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times the MRHD for clindamycin and 3.6, 10.8, and 60 times the MRHD for benzoyl peroxide, respectively, based on BSA comparisons) did not cause any increase in tumors.

However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900, and 3000 mg/kg/day (1.2, 3.6, and 12 times the MRHD for clindamycin and 2.4, 7.2, and 24 times the MRHD for benzoyl peroxide, respectively, based on BSA comparisons) for up to 97 weeks did not cause any increase in tumors.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin.

Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the MRHD for clindamycin, based on BSA comparisons) revealed no effects on fertility or mating ability.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Clindamycin Phosphate (klin-da-MYE-sin fos-fate) and Benzoyl Peroxide (BEN-zoe-il peer OKS-ide) Gel, 1.2%/2.5% Important information : Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is for use on skin only (topical use). Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in your mouth, eyes, or vagina. What is Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%?

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is safe and effective for use longer than 12 weeks. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is safe and effective in children under 12 years of age.

Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel,1.2%/2.5% if you have: had an allergic reaction to clindamycin, benzoyl peroxide, lincomycin or any of the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. See the end of this leaflet for a complete list of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. Crohn’s disease or ulcerative colitis. had inflammation of the colon (colitis), or severe diarrhea with past antibiotic use.

Talk with your doctor if you are not sure if you have any of the conditions listed above. Before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, tell your doctor about all of your medical conditions, including if you: plan to have surgery. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% may affect how certain medicines work that may be given during surgery. are pregnant or plan to become pregnant.

It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% passes into your breast milk. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk.

Talk to your doctor about the best way to feed your baby during treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% may affect the way other medicines work and other medicines may affect how Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% works.

Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should not be used with products that contain erythromycin. Tell your doctor about any skin products you use.

Other skin and topical acne products may increase the irritation of your skin when used with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%? Use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% exactly as your doctor tells you to use it. See the detailed “Instructions for Use” for directions about how to apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%.

Your doctor will tell you how long to use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. Apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to your face 1 time each day. What should I avoid while using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%?

Limit your time in sunlight. You should avoid using tanning beds or sunlamps during treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%. If you have to be in sunlight, wear a wide-brimmed hat or other prot… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE Clindamycin Phosphate (klin-da-MYE-sin fos-fate) and Benzoyl Peroxide (BEN-zoe-il peer-OKS-ide) Gel, 1.2%/2.5% Important Information: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is for use on skin only (topical use). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is not for use in your mouth, eyes or vagina Read this Instructions for Use before you start using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and each time you get a refill. There may be new information.

This information does not take the place of talking with your doctor about your medical condition or treatment. Apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to your face 1 time each day as prescribed. Before you apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.

To apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to your face, use the pump to dispense one pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% onto your fingertip. See Figure 1. One pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% should be enough to cover your entire face.

Figure 1 Dot the one pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2. Figure 2 Spread the gel over your face and gently rub it in.

It is important to spread the gel over your entire face. If your doctor tells you to put Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% on other areas of your skin with acne, be sure to ask how much you should use. Wash your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%.

How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%? Store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% at room temperature at or below 77°F (25°C). Do not freeze Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%.

Throw away (discard) Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% that has passed the expiration date. Store pump upright. Keep the container tightly closed.

Keep Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and all medicines out of the reach of children. The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo Allegan, MI 49010 www.perrigorx.com Rev 07-20 figure-1 figure-2

📄 Package Label / Principal Display Panel 6 words ▾

Clindamycin Phos/Benzoyl Peroxide Gel #50 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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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.