Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g
Clindamycin Phosphate, Benzoyl Peroxide · GEL · Bryant Ranch Prepack
Clindamycin Phosphate and Benzoyl Peroxide is a gel containing clindamycin phosphate, benzoyl peroxide at 25 mg/g, taken topical. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Clindamycin Phosphate and Benzoyl Peroxide
- Generic Name
- Clindamycin Phosphate, Benzoyl Peroxide
- NDC Code (Product)
72162-2077- Manufacturer
- Bryant Ranch Prepack
- Strength
- 25 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA205397
- Marketing Start
- 09/12/2019
Recall History
Valeant Pharmaceuticals North Am
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
L. Perrigo Company
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 )
Contraindications
4 CONTRAINDICATIONS 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) ].
Drug Interactions
7 DRUG INTERACTIONS 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.
Adverse Reactions
6 ADVERSE REACTIONS 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 percent…
Frequently Asked Questions
What is Clindamycin Phosphate and Benzoyl Peroxide used for?
Clindamycin Phosphate and Benzoyl Peroxide contains Clindamycin Phosphate, Benzoyl Peroxide. It is a gel taken topical. Consult your doctor for specific uses.
Is Clindamycin Phosphate and Benzoyl Peroxide a controlled substance?
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?
The generic name for Clindamycin Phosphate and Benzoyl Peroxide is Clindamycin Phosphate, Benzoyl Peroxide. There are no other listed brand versions of Clindamycin Phosphate, Benzoyl Peroxide.
What is the NDC code for Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g?
The NDC (National Drug Code) for Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g is 72162-2077, listed by Bryant Ranch Prepack.
Other Clindamycin Phosphate and Benzoyl Peroxide Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)