Medicine guide

Clindamycin Phosphate and Benzoyl Peroxide

10 mg/g + 25 mg/g · Gel

Prescription only
Lincosamide Antibacterial

Active substance: Clindamycin Phosphate and Benzoyl Peroxide
Used in: Antibiotics, antivirals and antifungals taken into the body
Made by: Sun Pharmaceutical Industries, Inc.
Source: Official label

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 · 2025-07-03

What it is

Lincosamide Antibacterial

Used for

Clindamycin phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Do not take it if

Clindamycin phosphate and benzoyl peroxide gel is contraindicated in:

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

16other products contain Clindamycin Phosphate 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 phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older.
( 1 )

From the official label · 2025-07-03 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Peak level after0.81 h

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-07-03

Do not take it if

Clindamycin phosphate and benzoyl peroxide gel 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 )
4.1 Hypersensitivity Clindamycin phosphate and benzoyl peroxide gel 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 [see Postmarketing Experience (6.2) ].
4.2 Colitis/Enteritis Clindamycin phosphate and benzoyl peroxide gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ].

Quoted from the official label, section “Contraindications”.

How to take it

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

Before applying clindamycin phosphate and benzoyl peroxide gel, 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 to the face once daily.
Avoid the eyes, mouth, mucous membranes, or areas of broken skin.
Use of clindamycin phosphate and benzoyl peroxide gel 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 is not for oral, ophthalmic, or intravaginal use.
Apply a pea-sized amount of clindamycin phosphate and benzoyl peroxide gel to the face once daily.
( 2 ) Not for oral, ophthalmic, or intravaginal use.
( 2 )

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

Other warnings

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 should be discontinued if significant diarrhea occurs.
( 5.1 ) Ultraviolet Light and Environmental Exposure:
Minimize sun exposure following drug application.
( 5.2 )
5.1 Colitis 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 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.
5.2 Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application.
5.3 Concomitant 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no available data on clindamycin phosphate and benzoyl peroxide gel 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, 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 to 4% and 15 to 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 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, 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.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are no available data on clindamycin phosphate and benzoyl peroxide gel 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, 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 to 4% and 15 to 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 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, 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.
8.2 Lactation 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 and any potential adverse effects on the breastfed child from clindamycin phosphate and benzoyl peroxide gel or from the underlying maternal condition.
Clinical Considerations If used during lactation and clindamycin phosphate and benzoyl peroxide gel is applied to the chest, care should be taken to
avoid accidental ingestion by the infant.
8.4 Pediatric Use Safety and effectiveness of clindamycin phosphate and benzoyl peroxide gel in pediatric patients under the age of 12 have not been evaluated.
8.5 Geriatric Use Clinical trials of clindamycin phosphate and benzoyl peroxide gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

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

Other medicines

Avoid using clindamycin phosphate and benzoyl peroxide gel in combination with topical or oral erythromycin-containing products because of its clindamycin component.
( 7.1 )
7.1 Erythromycin Clindamycin phosphate and benzoyl peroxide gel 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.
7.2 Neuromuscular 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 should be used with caution in patients receiving such agents.

Quoted from the official label, section “Drug Interactions”.

Use in children

Safety and effectiveness of clindamycin phosphate and benzoyl peroxide gel in pediatric patients under the age of 12 have not been evaluated.

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

Use in older people

Clinical trials of clindamycin phosphate and benzoyl peroxide gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

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

Side effects

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 Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 patients treated with clindamycin phosphate and benzoyl peroxide gel:
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) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod.
Mod. = Moderate 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
6.2 Postmarketing 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.

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

What to discuss with your doctor

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 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 may bleach hair or colored fabric.

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

Strengths and forms

FORMS AND STRENGTHS Gel, 1.2%/2.5% Each gram of clindamycin phosphate and benzoyl peroxide gel 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

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

What it looks like and how it is packed

16.1 How Supplied Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a white to off-white smooth gel supplied as:
NDC 51672-1367-3 50 gram pump
16.2 Dispensing Instructions for the Pharmacist Dispense clindamycin phosphate and benzoyl peroxide gel with a 10-week expiration date.
Specify " Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Do not freeze."
16.3 Storage and Handling PHARMACIST:
Prior to Dispensing:
Store in a refrigerator, 2° to 8°C (36° to 46°F).
PATIENT: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from freezing.
Store pump upright.
Keep out of the reach of children.
Keep container tightly closed.

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

How to store it

PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F).
PATIENT: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from freezing.
Store pump upright.
Keep out of the reach of children.
Keep container tightly closed.

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

What is in it

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 -D-galacto-octopyranoside 2 -(dihydrogen phosphate).
The structural formula for 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 contains the following inactive ingredients:
carbomer homopolymer type C, poloxamer 124, potassium hydroxide, propylene glycol, and purified water.
Each gram of clindamycin phosphate and benzoyl peroxide gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin.
Chemical Structure Chemical Structure

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.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

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 (4)

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

Showing 4 of 4

Details

Made by	Sun Pharmaceutical Industries, Inc.
Active substance	Clindamycin Phosphate and Benzoyl Peroxide
Used in	Antibiotics, antivirals and antifungals taken into the body
Strength	10 mg/g + 25 mg/g
Form	Gel
Route	Topical
Packs	1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP
NDC	51672-1367

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

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

Gel13 products
- 10 mg/g + 25 mg/g3
  10 mg/g + 25 mg/g · 3 companies
  - Encube Ethicals, Inc.
  - Oceanside Pharmaceuticals
  - Sun Pharmaceutical Industries, Inc. · this page
- 10 mg/g + 37.5 mg/g4
  10 mg/g + 37.5 mg/g · 4 companies
- 10 mg/g + 50 mg/g4
  10 mg/g + 50 mg/g · 4 companies
- 25 mg/g + 10 mg/g2
  25 mg/g + 10 mg/g · 2 companies
  - Bryant Ranch Prepack
  - Padagis Israel Pharmaceuticals Ltd
Kit2 products
- —2
  — · 2 companies
  - Mylan Pharmaceuticals Inc.
  - Sun Pharmaceutical Industries, Inc.

Same active substance

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

See every product with Clindamycin Phosphate and Benzoyl Peroxide