Medicine guide

Clindamycin Phosphate and Benzoyl Peroxide

10 mg/g + 50 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: Zydus Pharmaceuticals USA 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 · 2022-10-05

What it is

Lincosamide Antibacterial

Used for

Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris.

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

( 1.1 ) Limitation of Use:

Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris.
Clindamycin phosphate and benzoyl peroxide gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.
( 1.2 )
1.1 Indication Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.
1.2 Limitations of Use Clindamycin phosphate and benzoyl peroxide gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

From the official label · 2022-10-05 · DailyMed

How it works

From this product’s own US prescribing label.

Clindamycin Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology ( 12.4 )].
Benzoyl Peroxide Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects, but the precise mechanism of action is unknown.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2022-10-05

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 ) Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis).
( 4 )
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 Adverse Reactions ( 6.2 ).]
4.2 Colitis/Enteritis Clindamycin phosphate and benzoyl peroxide gel is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous 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.

Apply a thin layer of clindamycin phosphate and benzoyl peroxide gel to the face once daily, in the evening or as directed by the physician.
The skin should be gently washed, rinsed with warm water, and patted dry before applying clindamycin phosphate and benzoyl peroxide gel.
Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin.
Clindamycin phosphate and benzoyl peroxide gel is not for oral, ophthalmic, or intravaginal use.
Apply a thin layer of clindamycin phosphate and benzoyl peroxide gel to the face once daily, in the evening.
( 2 ) Not for oral, ophthalmic, or intravaginal use.
( 2 )

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

Other warnings

Colitis: Clindamycin can cause severe colitis, which may result in death.
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin.
Clindamycin phosphate and benzoyl peroxide gel should be discontinued if significant diarrhea occurs.
( 5.1 ) Ultraviolet light and environmental exposure (including use of tanning beds or sun lamps):
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.
If 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 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.
Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
5.2 Ultraviolet Light and Environmental Exposure Benzoyl peroxide, a component of clindamycin phosphate and benzoyl peroxide gel, may cause increased sensitivity to sunlight.
Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. [See Nonclinical Toxicology ( 13.1 ).] Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate and benzoyl peroxide gel.
Clindamycin phosphate and benzoyl peroxide gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m 2 , respectively) revealed no evidence of teratogenicity.
It is not known whether clindamycin phosphate and benzoyl peroxide gel is excreted into 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.
Because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and benzoyl peroxide gel is administered to a nursing woman.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate and benzoyl peroxide gel.
Clindamycin phosphate and benzoyl peroxide gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m 2 , respectively) revealed no evidence of teratogenicity.
8.3 Nursing Mothers It is not known whether clindamycin phosphate and benzoyl peroxide gel is excreted into 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.
Because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and benzoyl peroxide gel is administered to a nursing woman.
8.4 Pediatric Use Safety and effectiveness of clindamycin phosphate and benzoyl peroxide gel in pediatric patients below the age of 12 have not been established.
8.5 Geriatric Use Clinical studies of clindamycin phosphate and benzoyl peroxide gel did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.

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

Other medicines

Clindamycin phosphate and benzoyl peroxide gel should not be used in combination with erythromycin-containing products because of its clindamycin component.
( 7.1 )
Erythromycin
Avoid using clindamycin phosphate and benzoyl peroxide gel in combination with 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 Concomitant Topical Medications Concomitant topical acne therapies 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.
7.3 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
Clindamycin phosphate and benzoyl peroxide gel should be used with caution in patients receiving such agents.
7.4 Topical Sulfone Products Use of topical benzoyl-peroxide-containing preparations with topical sulfone products may cause skin and facial hair to temporarily change color (yellow/orange).

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

Use in children

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

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

Use in older people

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

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

Side effects

The following adverse reaction is described in more detail in the Warnings and Precautions section of the label:
Colitis [see Warnings and Precautions ( 5.1 )] .
The most common local adverse reactions (≥ 5%) are erythema, peeling, dryness, and burning.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 397 subjects used clindamycin phosphate and benzoyl peroxide gel once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris.
All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale:
0 = absent, 1 = mild, 2 = moderate, and 3 = severe.
The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table 1.
Table 1 Local Skin Reactions with Use of Clindamycin Phosphate and Benzoyl Peroxide Gel Combined Results from Five Trials (n = 397) % of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel with Symptom Present Before Treatment (Baseline) During Treatment Symptom Mild Moderate Severe Mild Moderate Severe Erythema 28% 3% 0 26% 5% 0 Peeling 6% <1% 0 17% 2% 0 Burning 3% <1% 0 5% <1% 0 Dryness 6% <1% 0 15% 1% 0 (Percentages derived by number of subjects receiving clindamycin phosphate and benzoyl peroxide gel with symptom score/number of enrolled subjects receiving clindamycin phosphate and benzoyl peroxide gel).
6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of clindamycin phosphate and benzoyl peroxide gel.
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 hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel.
Urticaria, application site reactions, including discoloration have been reported.

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

Strengths and forms

FORMS AND STRENGTHS Gel, 1.2%/5% Clindamycin phosphate and benzoyl peroxide gel is a white to off white gel.
Each gram of clindamycin phosphate and benzoyl peroxide gel contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.
Gel, 1.2%/5%:
Each gram of Clindamycin phosphate and benzoyl peroxide gel contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.
( 3 )

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%/5% is a white to off white gel and supplied as follows:
NDC 70710-1445-4 in tube of 45 grams
16.2 Storage and Handling Pharmacist:
Prior to Dispensing:
Store in a cold place, preferably in a refrigerator, between 2°C and 8°C (36°F and 46°F).
Do not freeze.
16.3 Dispensing Instructions for the Pharmacist Dispense clindamycin phosphate and benzoyl peroxide gel with a 60-day expiration date.
Specify "Store at room temperature up to 25°C (77°F).
Do not freeze." Keep tube tightly closed.
Keep out of the reach of small children.
Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is a white to off white gel and supplied as follows:
NDC 70710-1445-4 in tube of 45 grams

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

How to store it

Pharmacist:
Prior to Dispensing:
Store in a cold place, preferably in a refrigerator, between 2°C and 8°C (36°F and 46°F). Do not freeze.

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

What is in it

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to off white gel formulation.
Clindamycin phosphate, USP 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.
Clindamycin phosphate, USP is C 18 H 34 ClN 2 O 8 PS and is a white or almost white, hygroscopic crystalline powder and soluble in water, practically insoluble in dichloromethane, chloroform, benzene and ether.
The structural formula for clindamycin phosphate is represented below:
Clindamycin phosphate has a molecular weight of 504.96 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 - D-D- galacto -octopyranoside 2-(dihydrogen phosphate).
Benzoyl peroxide, USP is C 14 H 10 O 4 .
It has the following structural formula:
Hydrous benzoyl peroxide, USP has a molecular weight of 242.23.
It is white or almost white amorphous or granular powder and practically insoluble in water, slightly soluble in alcohol, soluble in acetone, in chloroform, in dichloromethane and in ether with separation of water Each gram of clindamycin phosphate and benzoyl peroxide gel contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.
Image Image

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 by	Zydus Pharmaceuticals USA Inc.
Active substance	Clindamycin Phosphate and Benzoyl Peroxide
Used in	Antibiotics, antivirals and antifungals taken into the body
Strength	10 mg/g + 50 mg/g
Form	Gel
Route	Topical
Packs	1 TUBE in 1 CARTON / 45 g in 1 TUBE
NDC	70710-1445

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 + 50 mg/g4
  10 mg/g + 50 mg/g · 4 companies
  - Padagis Israel Pharmaceuticals Ltd
  - Sun Pharmaceutical Industries, Inc.
  - Zydus Lifesciences Limited
  - Zydus Pharmaceuticals USA Inc. · this page
- 10 mg/g + 25 mg/g3
  10 mg/g + 25 mg/g · 3 companies
- 10 mg/g + 37.5 mg/g4
  10 mg/g + 37.5 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