Acnil Liniment
NDC 84277-5647
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Acnil (acnil clindamycin hydrochloride and metronidazole liniment) is a UNAPPROVED DRUG OTHER-approved product labeled by Jiangsu Chenpai Bond Pharmaceutical Co.,ltd.. This medication is typically used as a decreased sebaceous gland activity [pe]. It is supplied as a liniment for topical administration. This product entry covers the primary NDC 84277-5647 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
84277-5647
Proprietary Name:
Acnil
Non-Proprietary Name: [1]
Acnil Clindamycin Hydrochloride And Metronidazole Liniment
Substance Name: [2]
Clindamycin Hydrochloride; Metronidazole
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Liniment
- A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
84277
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
05-01-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 84277-5647?
The NDC code 84277-5647 is assigned by the FDA to the product Acnil. It is commonly known by its generic name, acnil clindamycin hydrochloride and metronidazole liniment. This pharmaceutical product is labeled by Jiangsu Chenpai Bond Pharmaceutical Co.,ltd. and is currently categorized as listed product. The medication is a liniment administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 84277-5647-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
PHARMACOLOGY AND TOXICOLOGY Clindamycin Hydrochloride is a bacteriostatic antibiotic, which is 4 to 8 times more potent than Lincomycin. It has potent antibacterial activity to aerobic gram-positive bacterium, such as Staphylococcus, Streptococcus, Bacillus diphtheriae and Bacillus anthracis. It also has good antibacterial activity to anaerobic gram-negative bacterium. Bacteroides (including bacteroides fragilis) and Clostridium are morbidly susceptible to it. It binds exclusively to the 50'S subunit of sensitive bacterial ribosome and suppresses protein synthesis. Clindamycin is a bacteriostat, but can kill high sensitive bacterium at high concentration. Metronidazole is an anti-anaerobic bacterial, anti-trichomonal and anti-amebic agent. Combination of Clindamycin Hydrochloride and Metronidazole can kill Propionibacterium acnes, Pityrosporum ovale, and some other sensitive bacterium and vermiform mite, and can inhibit them from growing. As a result, it can reduce the creation of lipase, and prevent triacylglycerol from hydrolyzing into free fatty acid.INDICATIONS It is indicated for the treatment of acne (especially for the acne pustulosa, cystic acne), tympanitis, nasosinusitis, folliculitis, and other bacterial infection on skin. It is also indicated for the supportive treatment of seborrheic dermatitis and brandy nose.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- CLINDAMYCIN HYDROCHLORIDE 10 mg/30mL - An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.
- METRONIDAZOLE 8 mg/30mL - A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
