ACNIL- acnil clindamycin hydrochloride and metronidazole liniment liniment

Acnil by

Drug Labeling and Warnings

Acnil by is a Otc medication manufactured, distributed, or labeled by Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Content of Labeling

INGREDIENTS AND APPEARANCE

ACNIL 
acnil clindamycin hydrochloride and metronidazole liniment liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84277-5647
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)	METRONIDAZOLE	8 mg  in 30 mL
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)	CLINDAMYCIN	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
2-(ETHYLTHIO)ETHANOL (UNII: 6091RQ1378)
GLYCEROL FORMAL (UNII: 3L7GR2604E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84277-5647-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2024

Labeler - Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd. (561021529)

Registrant - Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd. (561021529)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.		561021529	manufacture(84277-5647)