clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel — NDC 68462-486-27 (Billing 68462-0486-27)
This is a package of clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel from Glenmark Pharmaceuticals Inc., USA, marketed since Mar 2019 and currently FDA-listed; retail pharmacies pay about $0.5007 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68462-486-27 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68462 labeler · 486 product · 27 package
- Package marketed since
- Mar 14, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0368462859247, 0368462857861, 0368462484692, 0368462484869 +1 more
- Medicaid fills, this package
- 12,867 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 037628
- GCN: 08205
- GPI-14 (Medi-Span): 90059902194020
- HICL (First Databank): 017263
- AHFS class code: 08:12.28.20
- RxCUI (RxNorm): 358917
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Peroxides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.501 | $25.04 / 50 g |
| Medicaid paysCMS SDUD · 12 mo | $0.8547 | $42.74 / 50 g |
| Medicare drug plans payPart D · Q2 2026 | $1.02 | $50.84 / 50 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68462-0486-19 68462-486-19 | 1 JAR in 1 CARTON / 25 g in 1 JAR | $0.7423 / g | $18.56 | 2019-03-14 | — | Active |
| 68462-0486-24 68462-486-24 | 1 JAR in 1 CARTON / 35 g in 1 JAR | — | — | 2019-05-07 | — | Active |
| 68462-0486-27 You're viewing this Main listing | 1 JAR in 1 CARTON / 50 g in 1 JAR | $0.5007 / g | $25.04 | 2019-03-14 | — | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.5007 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 63% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/gthis 68462-0486-27 | Glenmark | 1 jar | $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 | +48% |
| Clindamycin and Benzoyl Peroxide 21922-0068-43 | Encube | 1 kit | $0.742 | AB | Availability likely | +48% |
| clindamycin and benzoyl peroxide 45802-0509-01 | Padagis | 1 kit | $0.742 | AB | Availability likely | +48% |
| clindamycin and benzoyl peroxide 45802-0507-04 | Padagis | 1 kit | $0.901 | AB | Availability likely | +80% |
| clindamycin and benzoyl peroxide 45802-0510-03 | Padagis | 1 kit | $1.128 | AB | Availability likely | +125% |
| clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 68462-0859-24 | Glenmark | 1 bottle | $1.128 | AB | Availability likely | +125% |
| Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 50 mg/g 70771-1450-04 | Zydus | 1 tube | — | AB | FDA listed | — |
| Clindamycin And Benzoyl Peroxide 72162-2074-02 | Bryant | 1 kit | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
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UNII F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Glenmark Pharmaceuticals Inc., USA labeler code 68462
- Ursodiol 250 mg Tablet NDC 68462-473-01
- Ursodiol 500 mg Tablet NDC 68462-474-01
- Vancomycin Hydrochloride 750 mg Injection, Powder, Lyophilized, For Solution NDC 68462-477-74
- Vancomycin Hydrochloride 1.25 g Injection, Powder, Lyophilized, For Solution NDC 68462-478-84
- Vancomycin Hydrochloride 1.5 g Injection, Powder, Lyophilized, For Solution NDC 68462-479-84
- CLOBETASOL PROPIONATE .05 g/mL Spray NDC 68462-480-39
- deferasirox 125 mg Tablet, For Suspension NDC 68462-494-30
- deferasirox 250 mg Tablet, For Suspension NDC 68462-495-30
- deferasirox 500 mg Tablet, For Suspension NDC 68462-496-30
- Zolmitriptan 2.5 mg Tablet, Film Coated NDC 68462-497-76
- Zolmitriptan 5 mg Tablet, Film Coated NDC 68462-498-33
- zolmiptriptan zolmitriptan 2.5 mg Tablet, Orally Disintegrating NDC 68462-499-76
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Clindamycin and Benzoyl Peroxide Gel 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 ▾
CONTRAINDICATIONS Clindamycin and Benzoyl Peroxide Gel 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 ▾
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 ▾
ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel 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 gel and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and Benzoyl Peroxide 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 ▾
Pregnancy: Teratogenic Effects: Animal reproductive/developmental toxicity studies have not been conducted with clindamycin and benzoyl peroxide gel 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 Gel . It also is not known whether Clindamycin and Benzoyl Peroxide Gel can cause fetal harm when administered to a pregnant woman.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY An in vitro percutaneous penetration study comparing Clindamycin and Benzoyl Peroxide Gel 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 Gel 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 Gel was studied in male and female patients (n=13) with acne vulgaris.
Clindamycin and Benzoyl Peroxide Gel (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1 ng/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 to 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 Gel . 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 ▾
HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS NDC Number Size (Net Weight) Benzoyl Peroxide Gel (in a jar) *includes pump Active Clindamycin powder (in plastic vial) Purified Water to be added to each vial 68462-486-19 19.7 g (68462-485-19) 0.3 g (68462-484-69) 5 mL 68462-485-24 35 g Carton 27.6 g (68462-485-24) 0.4 g (68462-484-98) 7 mL 68462-486-27 50 g Carton 39.4 g (68462-485-27) 0.6 g (68462-484-86) 10 mL 68462-859-24 35 g Pump Carton 27.6* (68462-858-24) 0.4 g (68462-857-98) 7 mL 68462-859-27 50 g Pump Carton 39.4* (68462-858-27) 0.6 g (68462-857-86) 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 Gel (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 ▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep tightly closed. Keep out of reach of children. Rx Only Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2025 logo
📋 Description ▾
DESCRIPTION Clindamycin and Benzoyl Peroxide 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 504.96 g/mol 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 - α -D- galacto -octopyranoside 2-(dihydrogen phosphate). Clindamycin and Benzoyl Peroxide 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 g/mol. Each gram of Clindamycin and Benzoyl Peroxide 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, docusate sodium, edetate disodium, sodium hydroxide and purified water. clinidamycin-structure benzoyl-peroxide
💬 Information for Patients ▾
Information for Patients: Patients using Clindamycin and Benzoyl Peroxide Gel should receive the following information and instructions: 1. Clindamycin and Benzoyl Peroxide Gel 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 gel. 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 Gel and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician. 6.
Clindamycin and Benzoyl Peroxide Gel may bleach hair or colored fabric. 7. Clindamycin and Benzoyl Peroxide Gel 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 Gel to affected areas wash the skin gently, then rinse with warm water and pat dry.
⚠️ Precautions ▾
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 non-susceptible 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 Gel should receive the following information and instructions: 1.
Clindamycin and Benzoyl Peroxide Gel 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 gel.
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 Gel and contact their physician immediately.
In addition, patients should report any signs of local adverse reactions to their physician. 6. Clindamycin and Benzoyl Peroxide Gel may bleach hair or colored fabric.
7. Clindamycin and Benzoyl Peroxide Gel 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 Gel 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 gel 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 gel 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 gel, 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 gel. 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… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Women: It is not known whether Clindamycin and Benzoyl Peroxide Gel 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 ▾
Pharmacokinetics: The pharmacokinetics (plasma and urine) of clindamycin from Clindamycin and Benzoyl Peroxide Gel was studied in male and female patients (n=13) with acne vulgaris. Clindamycin and Benzoyl Peroxide Gel (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1 ng/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 to 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 Gel . The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold.
🔬 Clinical Studies ▾
CLINICAL STUDIES In two adequate and well controlled clinical studies of 758 patients, 214 used clindamycin and benzoyl peroxide gel, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. Clindamycin and benzoyl peroxide gel 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 gel 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 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 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 gel group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
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 gel 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 gel 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 gel, 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 gel. 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 Gel 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 gel, based on mg/m 2 ) revealed no effects on fertility or mating ability.
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