Label: ACNIL- acnil clindamycin hydrochloride and metronidazole liniment liniment

  • NDC Code(s): 84277-5647-1
  • Packager: Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 30, 2024

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  • WARNINGS

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION For external use only. Drip 1~2 drops of Acnil to affected area, or dip some Acnil in cotton bud and apply to the affected area. It should be applied three times daily. Two weeks’ treatment constitutes a single therapeutic course. Repeat another therapeutic course if it is necessary.

  • WARNINGS

    ADVERSE REACTIONS: A few instance of local irritation or burning sensation may be observed. occasionally during the treatment. Allergic reaction can be observed rarely.

  • INACTIVE INGREDIENT

    8.0 mg of Metronidazole.

  • INDICATIONS & USAGE

    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.

  • KEEP OUT OF REACH OF CHILDREN

    WARNINGS: General: 1. If any irritation or other adverse reactions occurred, stop or reduce the drug, and consult a doctor. 2. It should not be used for long, because it may induce tolerance to bacterium. 3. Keep out of reach of children.

  • PURPOSE

    DESCRIPTION Acolorless or slightly yellow clear liquid; with an odour of alcohol.

    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.

    Drug Interactions: There is antagonism between ACNIL and erythromycin, so the combination of ACNIL and erythromycin is forbidden.

  • ACTIVE INGREDIENT

    It is a compound preparation. Each milliliter contains 10.0 mg of Clindamycin Hydrochloride (calculated as Clindamycin),

  • PRINCIPAL DISPLAY PANEL

    Package LabelContent of LabelingContent of Labeling

  • INGREDIENTS AND APPEARANCE
    ACNIL 
    acnil clindamycin hydrochloride and metronidazole liniment liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84277-5647
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE8 mg  in 30 mL
    CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    2-(ETHYLTHIO)ETHANOL (UNII: 6091RQ1378)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84277-5647-130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2024
    Labeler - Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd. (561021529)
    Registrant - Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd. (561021529)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.561021529manufacture(84277-5647)