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Clindamycin and Benzoyl Peroxide Kit — NDC 72162-2074-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clindamycin and Benzoyl Peroxide Kit — NDC 72162-2074-2 (Billing 72162-2074-02)

by Bryant Ranch Prepack · 1 KIT in 1 CARTON * .6 g in 1 VIAL * 39.4 g in 1 JAR

This is a package of Clindamycin and Benzoyl Peroxide Kit from Bryant Ranch Prepack, marketed since Sep 2015 and currently FDA-listed. It is this product's only package size.

NDC 72162-2074-02
🏷️ FDA NDC (as labeled) 72162-2074-2 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

NDC database record

One package, one record: these facts belong to NDC 72162-2074-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72162 labeler · 2074 product · 2 package
Package marketed since
Aug 15, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7216220742 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72162-2074-2
Product NDC 72162-2074
11-digit billing NDC 72162207402
NCPDP billing unit GM — per gram (weight)
RxCUI 308694, 358917
Application # ANDA202440
SPL Set ID 30d311b4-9058-4ebf-898e-17ba66294500
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-22
Dosage form KIT
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 063953
GCN 99665
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 CLINDAMYCIN-BNZ PEROX 1-5% PMP
FDB brand name Clindamycin-Benzoyl Peroxide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063953
  • GCN: 99665
  • HICL (First Databank): 017263
  • AHFS class code: 08:12.28.20
  • RxCUI (RxNorm): 308694
Why two NDCs? The FDA registers this code as 72162-2074-2 — 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 → 72162-2074-02. 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 Peroxides class.

Drug family (ATC) Peroxides
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.

Clinical

Label name CLINDAMYCIN-BNZ PEROX 1-5% PMP Ingredient Clindamycin Phos/Benzoyl Perox
📖 What it is MedlinePlus · NLM

The combination of clindamycin and benzoyl peroxide is used to treat acne. Clindamycin and benzoyl peroxide are in a class of medications called topical antibiotics. The combination of clindamycin and benzoyl peroxide works by killing the bacteria that cause acne.

Read the full MedlinePlus article ↗

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 eachPer 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 · Q2 2026 $1.02 —
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
72162-2074-02 You're viewing this Main listing 1 KIT in 1 CARTON * .6 g in 1 VIAL * 39.4 g in 1 JAR 2023-08-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin Phosphate and Benzoyl Peroxide 00378-8688-54 Mylan 1 kit $0.501 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 51672-1381-04 Sun 1 kit $0.501 AB Availability likely —
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 16714-0984-25 NorthStar 1 jar $0.742 AB Availability likely —
Clindamycin and Benzoyl Peroxide 21922-0068-43 Encube 1 kit $0.742 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0509-01 Padagis 1 kit $0.742 AB Availability likely —
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 68462-0486-19 Glenmark 1 jar $0.742 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0507-04 Padagis 1 kit $0.901 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0510-03 Padagis 1 kit $1.128 AB Availability likely —
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 68462-0859-24 Glenmark 1 bottle $1.128 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 50 mg/g 70771-1450-04 Zydus 1 tube — AB FDA listed —
Clindamycin And Benzoyl Peroxidethis 72162-2074-02 Bryant 1 kit — 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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 applicationANDA202440 (ANDA)
Labeler code72162
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 72162

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE Clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

⏱️ Dosage and Administration 40 words ▾

DOSAGE AND ADMINISTRATION Clindamycin and benzoyl peroxide topical gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

⛔ Contraindications 42 words ▾

CONTRAINDICATIONS Clindamycin and benzoyl peroxide topical gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

⚠️ Warnings 217 words ▾

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 ABSORPTION OF THE ANTIBIOTIC 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 Clostridium 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. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.

In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

🤒 Adverse Reactions 175 words ▾

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide topical gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide topical gel, 1%/5% and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and benzoyl peroxide topical gel, 1%/5% n=420 Vehicle n=168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 8 (2%) 1 (<1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (<1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. 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.

🤰 Pregnancy 137 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproductive/developmental toxicity studies have not been conducted with clindamycin and benzoyl peroxide topical gel, 1%/5% or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m 2 , respectively) revealed no evidence of teratogenicity.

There are no well-controlled trials in pregnant women treated with clindamycin and benzoyl peroxide topical gel, 1%/5%. It also is not known whether clindamycin and benzoyl peroxide topical gel, 1%/5% can cause fetal harm when administered to a pregnant woman.

🧒 Pediatric Use 20 words ▾

Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY An in vitro percutaneous penetration study comparing clindamycin and benzoyl peroxide topical gel, 1%/5% and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in clindamycin and benzoyl peroxide topical gel, 1%/5% is suggested to be less than 1%. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle. Pharmacokinetics: The pharmacokinetics (plasma and urine) of clindamycin from clindamycin and benzoyl peroxide topical gel, 1%/5% was studied in male and female patients (n=13) with acne vulgaris.

Clindamycin and benzoyl peroxide topical gel, 1%/5% (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5. Peak plasma concentrations (C max ) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5.

The AUC (0-12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5. The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5. The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04).

A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of clindamycin and benzoyl peroxide topical gel, 1%/5%. The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold. Microbiology: The clindamycin and benzoyl peroxide components 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 was not examined in clinical trials with this product.

📦 How Supplied / Storage and Handling 142 words ▾

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS Size (Net Weight) NDC Benzoyl Peroxide Gel Active Clindamycin Powder (In plastic vial) Purified Water To Be Added to each vial 50 grams (pump) 72162-2074-2 39.4g 0.6g 10 mL Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark.

Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Clindamycin and benzoyl peroxide topical gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months.

Place a 3 month expiration date on the label immediately following mixing.

📦 Storage and Handling 23 words ▾

Store at room temperature up to 25ºC (77ºF) {See USP}. Do not freeze. Keep tightly closed. Keep out of the reach of children.

📋 Description 158 words ▾

DESCRIPTION Clindamycin and benzoyl peroxide topical gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS).

The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D-galacto- octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide topical gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ).

It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide topical gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.

💬 Information for Patients ~1 min read ▾

Information for Patients: Patients using clindamycin and benzoyl peroxide topical gel, 1%/5% should receive the following information and instructions: 1. Clindamycin and benzoyl peroxide topical gel, 1%/5% is to be used as directed by the physician. It is for external use only.

Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. Patients should not use any other topical acne preparation unless otherwise directed by physician. 4.

Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using clindamycin and benzoyl peroxide topical gel, 1%/5%. To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used. 5.

Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue clindamycin and benzoyl peroxide topical gel, 1%/5% and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician. 6.

Clindamycin and benzoyl peroxide topical gel, 1%/5% may bleach hair or colored fabric. 7. Clindamycin and benzoyl peroxide topical gel, 1%/5% can be stored at room temperature up to 25°C (77°F) for 3 months.

Do not freeze. Discard any unused product after 3 months. 8.

Before applying clindamycin and benzoyl peroxide topical gel, 1%/5% to affected areas wash the skin gently, then rinse with warm water and pat dry.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: For dermatological use only; not for ophthalmic use. 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. The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms including fungi.

If this occurs, discontinue use of this medication and take appropriate measures. Avoid contact with eyes and mucous membranes. Clindamycin and erythromycin containing products should not be used in combination.

In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known. Information for Patients: Patients using clindamycin and benzoyl peroxide topical gel, 1%/5% should receive the following information and instructions: 1.

Clindamycin and benzoyl peroxide topical gel, 1%/5% is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.

2. This medication should not be used for any disorder other than that for which it was prescribed. 3.

Patients should not use any other topical acne preparation unless otherwise directed by physician. 4. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using clindamycin and benzoyl peroxide topical gel, 1%/5%.

To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used. 5. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue clindamycin and benzoyl peroxide topical gel, 1%/5% and contact their physician immediately.

In addition, patients should report any signs of local adverse reactions to their physician. 6. Clindamycin and benzoyl peroxide topical gel, 1%/5% may bleach hair or colored fabric.

7. Clindamycin and benzoyl peroxide topical gel, 1%/5% can be stored at room temperature up to 25°C (77°F) for 3 months. Do not freeze.

Discard any unused product after 3 months. 8. Before applying clindamycin and benzoyl peroxide topical gel, 1%/5% to affected areas wash the skin gently, then rinse with warm water and pat dry.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.

In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of clindamycin and benzoyl peroxide topical gel, 1%/5% with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation). In a 2-year dermal carcinogenicity study in rats, treatment with clindamycin and benzoyl peroxide topical gel, 1%/5% 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.

The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide topical gel, 1%/5%, based on mg/m 2 ) was statistically significantly higher than that in the sham- and vehicle-controls. Genotoxicity studies were not conducted with clindamycin and benzoyl peroxide topical gel, 1%/5%. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.

Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benz… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 72 words ▾

Nursing Women: It is not known whether clindamycin and benzoyl peroxide topical gel, 1%/5% is excreted in human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~1 min read ▾

Pharmacokinetics: The pharmacokinetics (plasma and urine) of clindamycin from clindamycin and benzoyl peroxide topical gel, 1%/5% was studied in male and female patients (n=13) with acne vulgaris. Clindamycin and benzoyl peroxide topical gel, 1%/5% (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5.

Peak plasma concentrations (C max ) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5. The AUC (0-12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5. The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5.

The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04). A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of clindamycin and benzoyl peroxide topical gel, 1%/5%. The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold.

🔬 Clinical Studies ~1 min read ▾

CLINICAL STUDIES In two adequate and well controlled clinical studies of 758 patients, 214 used clindamycin and benzoyl peroxide topical gel, 1%/5%, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. Clindamycin and benzoyl peroxide topical gel, 1%/5% applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10.

The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face.

Non-medicated make-up could be applied at one hour after the clindamycin and benzoyl peroxide topical gel, 1%/5% application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure.

Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below: Study 1 Clindamycin and benzoyl peroxide topical gel, 1%/5% n=120 Benzoyl peroxide n=120 Clindamycin n=120 Vehicle n=120 Mean percent reduction in inflammatory lesion counts 46% 32% 16% +3% Mean percent reduction in non-inflammatory lesion counts 22% 22% 9% +1% Mean percent reduction in total lesion counts 36% 28% 15% 0.2% Study 2 Clindamycin and benzoyl peroxide topical gel, 1%/5% n=95 Benzoyl peroxide n=95 Clindamycin n=49 Vehicle n=48 Mean percent reduction in inflammatory lesion counts 63% 53% 45% 42% Mean percent reduction in non-inflammatory lesion counts 54% 50% 39% 36% Mean percent reduction in total lesion counts 58% 52% 42% 39% The clindamycin and benzoyl peroxide topical gel, 1%/5% group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.

In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of clindamycin and benzoyl peroxide topical gel, 1%/5% with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation). In a 2-year dermal carcinogenicity study in rats, treatment with clindamycin and benzoyl peroxide topical gel, 1%/5% 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.

The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide topical gel, 1%/5%, based on mg/m 2 ) was statistically significantly higher than that in the sham- and vehicle-controls. Genotoxicity studies were not conducted with clindamycin and benzoyl peroxide topical gel, 1%/5%. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.

Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. 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. Studies have not been performed with clindamycin and benzoyl peroxide topical gel, 1%/5% or benzoyl peroxide to evaluate the effect on fertility.

Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide topical gel, 1%/5%, based on mg/m 2 ) revealed no effects on fertility or mating ability.

📄 Package Label / Principal Display Panel 5 words ▾

Clindamycin/Benzoyl 1%/5% Topical Gel Label

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

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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NDC identity (package / product / labeler codes) ✓ Available
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Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
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NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
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Where does this data come from?
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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.