Neuac

Neuac is an FDA-registered drug product whose active ingredient is CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE. It is labelled by Medimetriks Pharmaceuticals taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 43538-176, application ANDA090979, label effective 20231115. It is one of 5 FDA drug label records sharing the active ingredient CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE are most often described in connection with: benzoyl peroxide, clindamycin phosphate, topical treatment, inflammatory acne, additional benefit, same vehicle, usage neuac, gel combination. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Neuac ® (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: Neuac ® (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 Neuac ® (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 Neuac ® (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.

2 DOSAGE AND ADMINISTRATION Apply a thin layer of Neuac ® (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 Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5%. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin. Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of Neuac ® (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 )

4 CONTRAINDICATIONS Neuac ® (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 Neuac ® (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 Neuac ® (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) ].

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 Medimetriks Pharmaceuticals, Inc. at 973-882-7512 or the 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 Table 1. Table 1. Local Skin Reactions With Use Of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% Combined Results From Five Trials (n=397) % of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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, 1.2%/5% with symptom score/number of enrolled subjects receiving clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%. 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, 1.2%/5%. Urticaria, application site reactions, including discoloration have been reported.

FDA lists 5 drug label records with CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Neuac used for?
1 INDICATIONS AND USAGE Neuac ® (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: Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional …

Who makes Neuac?
Medimetriks Pharmaceuticals is the labeler of record for Neuac. 5 FDA label records share the active ingredient CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Neuac come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Neuac prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE?
Yes. 5 FDA drug label records list CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Neuac been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.