Drugplain

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 50 mg/g

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE · GEL · Encube Ethicals, Inc.

No Recall HistoryCurrently in Shortage
Plain English

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is a gel containing clindamycin phosphate and benzoyl peroxide at 50 mg/g, taken topical. Manufactured by Encube Ethicals, Inc..

Key Facts

Brand Name
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Generic Name
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
NDC Code (Product)
21922-022
Manufacturer
Encube Ethicals, Inc.
Strength
50 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
ANDA212433
Marketing Start
05/20/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

application site erythema5 reports
application site pain4 reports
drug ineffective3 reports
pruritus3 reports
skin discolouration3 reports
accidental exposure to product2 reports
application site irritation2 reports
back pain2 reports
disturbance in attention2 reports
musculoskeletal stiffness2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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, 1.2%/5% 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.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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, 1.2%/5%. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to the face once daily, in the evening. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

Contraindications

4 CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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, 1.2%/5% 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, 1.2%/5%. [See Adverse Reactions ( 6.2 ).] 4.2 Colitis/Enteritis Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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 )].

Drug Interactions

7 DRUG INTERACTIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should not be used in combination with erythromycin-containing products because of its clindamycin component. ( 7.1 ) 7.1 Erythromycin Avoid using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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, 1.2%/5% should be used with caution in pa…

Adverse Reactions

6 ADVERSE REACTIONS 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 Northstar Rx LLC at 1-800-206-7821 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, 1.2%/5% 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 T…

Frequently Asked Questions

What is CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE used for?

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE contains CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE. It is a gel taken topical. Consult your doctor for specific uses.

Is CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE a controlled substance?

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is not classified as a controlled substance by the DEA.

What is the generic name for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE?

The generic name for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE. There are 9 other brand versions of CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE.

What is the NDC code for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 50 mg/g?

The NDC (National Drug Code) for CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 50 mg/g is 21922-022, listed by Encube Ethicals, Inc..

Product NDC

21922-022

Package NDC

21922-022-06

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