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Medicine guide

Clindamycin and Benzoyl Peroxide

10 mg/g + 50 mg/g · Gel

  • Prescription only
  • Lincosamide Antibacterial
Made by
Glenmark Pharmaceuticals Inc., USA

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-31

What it is

Lincosamide Antibacterial

Used for
  • Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.
Do not take it if

Clindamycin and Benzoyl Peroxide Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
4other products contain Clindamycin and Benzoyl Peroxide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.

From the official label · 2026-01-31 · DailyMed

How it works

From this product’s own US prescribing label.

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%.

How it leaves the body

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-31

Do not take it if

  • 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.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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.

Quoted from the official label, section “Dosage & Administration”.

Other 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.
  • 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:
  • 1.
  • 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.
  • Pregnancy:
  • Pediatric Use:
  • 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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.
  • 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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

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

Quoted from the official label, section “Pediatric Use”.

Side effects

  • 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • 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.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • 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.

Quoted from the official label, section “How Supplied”.

How to store it

  • 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

Quoted from the official label, section “Storage and Handling”.

What is in it

  • 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (10)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 10 of 10

Details

Made byGlenmark Pharmaceuticals Inc., USA
Active substanceClindamycin and Benzoyl Peroxide
Used inAntibiotics, antivirals and antifungals taken into the body
Strength10 mg/g + 50 mg/g
FormGel
RouteTopical
Packs1 JAR in 1 CARTON / 25 g in 1 JAR · 1 JAR in 1 CARTON / 35 g in 1 JAR · 1 BOTTLE, PUMP in 1 CARTON / 35 g in 1 BOTTLE, PUMP
NDC68462-486
NDC68462-859

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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See every product with Clindamycin and Benzoyl Peroxide