JUJIAFENHUANGQUAN YINDAOSHUAN- policresulen vaginal suppository suppository
Jujiafenhuangquan Yindaoshuan by
Drug Labeling and Warnings
Jujiafenhuangquan Yindaoshuan by is a Otc medication manufactured, distributed, or labeled by Heilongjiang Tianlong Pharmaceutical Co Ltd. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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COMPONENTS
Instruction for Usage of Policresulen Vaginal Suppository
Please read the instruction carefully and use the product under the advice of doctor
Warning: during pregnancy, especially in the last three months of pregnancy, any treatment of the cervix should not be used, while the treatment of the vagina and its surrounding areas can only be used when absolutely necessary.
【Name】Policresulen Vaginal Suppository
Pin yin: Jujiafenhuangquan Yindaoshuan
【Ingredients】The main component of this product is Policresulen. Its chemical name is: m-cresol sulfonic acid and formaldehyde polymer.
【Character】This product is light red to light red brown suppository.
【Indication】It is used in the treatment of local inflammation or infection and tissue damage of vagina and cervix (eg, discharge due to bacterial, trichomonal and fungal infections, pressure sores from pessaries), condylomata acuminate, protuberance of cervical mucosa (cervical ectopia). For cervical erosion, cervicitis and different kinds of vaginitis.(Bacterial Vaginitis,Trichomonas Vaginitis,monilial vaginitis)pressure ulcer caused by Pessaries.
【Specification】8piece/box
【Usage and Dosage】 Vaginal administration, put the product into the deep part of the vagina, once every 2 days. If the affected part is burned with the Policresulen concentrated solution, a suppository should put in every other day between the two burns. For the convenience of use, the patient had better take the supine position, first wet the suppository with water, and then insert it into the deep part of vagina. Usually, it is better to use medicine before going to bed at night. Use with sanitary napkin together, to prevent pollution of clothes and bedding.
【Adverse Reactions】 Occasional local irritation will be occurred after treatment (such as burning or pain) usually can be tolerated and will soon disappear.
【Contraindications】 During pregnancy, especially in the last three months of pregnancy, any treatment of the cervix should not be used, while the treatment of the vagina and its surrounding areas can only be used when absolutely necessary.
【Precaution】
1. External use only, should not be taken orally.
2. This product should avoid contact with eyes.
3. This product will accelerate and enhance the repair process. If the necrotic tissue falls off from the focus, sometimes even a large sheet falls off. Do not panic.
4. Stop treatment during menstruation. Avoid sexual life during treatment. Do not use irritating soap to clean the affected area.
5. Cotton fabric and leather shall be washed with water immediately before the preparation is dry, when the solution contacting with them.
6. Spots on the vaginal suppository are the natural phenomena produced by its matrix, which do not affect the use and efficacy of the drug, nor affect its tolerance.
【Medication for pregnant women and lactating women】 During pregnancy, especially in the third trimester, any cervical treatment should be avoided, and the Policresulen suppository is no exception. At this time, the potential harm of the drug to the mother and baby should be fully considered. Although the animal test shows that the drug has no teratogenic effect, the results of the human test have not been obtained. It is unclear whether the milk of lactating women will contain the active ingredient of this medicine.
【Children Medication】The safety and efficacy of children patients have not been studied.
【Geriatric Medication】The safety and efficacy of elderly patients have not been studied.
【Drug Interactions】Policresulen can only be used locally. Since the interaction with other drugs cannot be ruled out, it is avoided to use more than two drugs at the same place at the same time.
【Pharmacology and Toxicology】
Pharmacological Action
The mechanism of action of policresulen is to kill bacteria, haze bacteria and trichomonad by strong acid and protein coagulation. Selectively cause necrosis or pathological tissue and columnar epithelial protein denaturation. It causes vasoconstriction and plasma protein coagulation to stop bleeding.
Policresulen has a wide range of antibacterial activities, including common gram-positive bacteria, Gram-negative bacteria, fungi and some viruses, of which Gardnerella vaginatis, anaerobic trichomonad and Candida are particularly sensitive. But Doderlein bacterial flora was not affected. At present, the drug has not been reported to cause drug resistance.
Policresulen can selectively coagulate necrotic or diseased tissues and promote tissue regeneration and epithelial re covering. Healthy squamous epithelium is unaffected, while the cytoplasm and nucleus of columnar epithelium may swell after contact with the drug, and then shrink in a few seconds. Local application of policresulen does not produce toxicity.
Toxicity Studying
More than 50 years of clinical experience has proved that the local use of policresulen is non-toxic.
Acute toxicity: The LD50 of mice was 360mg/kg after intravenous administration and 2400mg/kg after oral administration. The LD50 of rats was 400mg/kg intravenously and 3500mg/kg orally. The LD50 of mice is 200 times of the therapeutic dose of human beings, and the LD50 of rats is 300 times of the therapeutic dose of human beings.
Chronic toxicity: Rats and dogs were given 40 times and 9 times of the human treatment dose for 3 months, no related toxic effect was found.
The skin tolerance test of policresulen was carried out on the back of hair removing rats. In the first 10 days of the 14 day observation, the application of different concentrations of policresulen (4%, 11% and 36%) only caused temporary skin redness, which lasted until the third application at most.
Reproductive toxicity: The study on pregnant rats and rabbits shows that there was no embryotoxicity or teratogenicity effect on animals. teratogenicity
Mutagenicity/carcinogenicity: there is no relevant study on the carcinogenesis of this product. Ames test proves that policresulen has no mutagenic effect there is no relevant research on the carcinogenesis of this product. Ames test proves that policresulen has no mutagenicity effects. Although there is no research report on carcinogenesis of this product, no mutagenic or carcinogenic effect has been found in clinical application for many years.
【Pharmacokinetic】 Data are still lacking
【Shelf Life】 36 months
【Storage】Shading, airtight, stored below 25 ℃
【Package】 Medical polyethylene PVC composite packaging. 8 capsules per box. 8 medical plastic fingertips.
【Validity Period】 36 months
【Executive Standard】National Food and Drug Administration Standard YBH02122009
【Approval No. 】National Drug Approval No. H20093211
【Production Enterprise】
Name: Heilongjiang Tianlong Pharmaceutical Co., Ltd.
Address: NO.158, Jiuzhou Road, Industry Park, Harbin Science and Technology Innovation City, Harbin, China
Post code: 150020
Tel: 400-657-8838
Fax No.: 0451-87032629
Website: WW. Hutl. Com
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DOSAGE & ADMINISTRATION
【Indication】It is used in the treatment of local inflammation or infection and tissue damage of vagina and cervix (eg, discharge due to bacterial, trichomonal and fungal infections, pressure sores from pessaries), condylomata acuminate, protuberance of cervical mucosa (cervical ectopia). For cervical erosion, cervicitis and different kinds of vaginitis.(Bacterial Vaginitis,Trichomonas Vaginitis,monilial vaginitis)pressure ulcer caused by Pessaries.
【Specification】8piece/box
【Usage and Dosage】 Vaginal administration, put the product into the deep part of the vagina, once every 2 days. If the affected part is burned with the Policresulen concentrated solution, a suppository should put in every other day between the two burns. For the convenience of use, the patient had better take the supine position, first wet the suppository with water, and then insert it into the deep part of vagina. Usually, it is better to use medicine before going to bed at night. Use with sanitary napkin together, to prevent pollution of clothes and bedding.
- INACTIVE INGREDIENT
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INDICATIONS & USAGE
【Precaution】
1. External use only, should not be taken orally.
2. This product should avoid contact with eyes.
3. This product will accelerate and enhance the repair process. If the necrotic tissue falls off from the focus, sometimes even a large sheet falls off. Do not panic.
4. Stop treatment during menstruation. Avoid sexual life during treatment. Do not use irritating soap to clean the affected area.
5. Cotton fabric and leather shall be washed with water immediately before the preparation is dry, when the solution contacting with them.
6. Spots on the vaginal suppository are the natural phenomena produced by its matrix, which do not affect the use and efficacy of the drug, nor affect its tolerance.
【Medication for pregnant women and lactating women】 During pregnancy, especially in the third trimester, any cervical treatment should be avoided, and the Policresulen suppository is no exception. At this time, the potential harm of the drug to the mother and baby should be fully considered. Although the animal test shows that the drug has no teratogenic effect, the results of the human test have not been obtained. It is unclear whether the milk of lactating women will contain the active ingredient of this medicine.
【Children Medication】The safety and efficacy of children patients have not been studied.
【Geriatric Medication】The safety and efficacy of elderly patients have not been studied.
【Drug Interactions】Policresulen can only be used locally. Since the interaction with other drugs cannot be ruled out, it is avoided to use more than two drugs at the same place at the same time.
- KEEP OUT OF REACH OF CHILDREN
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PURPOSE
【Pharmacology and Toxicology】
Pharmacological Action
The mechanism of action of policresulen is to kill bacteria, haze bacteria and trichomonad by strong acid and protein coagulation. Selectively cause necrosis or pathological tissue and columnar epithelial protein denaturation. It causes vasoconstriction and plasma protein coagulation to stop bleeding.
Policresulen has a wide range of antibacterial activities, including common gram-positive bacteria, Gram-negative bacteria, fungi and some viruses, of which Gardnerella vaginatis, anaerobic trichomonad and Candida are particularly sensitive. But Doderlein bacterial flora was not affected. At present, the drug has not been reported to cause drug resistance.
Policresulen can selectively coagulate necrotic or diseased tissues and promote tissue regeneration and epithelial re covering. Healthy squamous epithelium is unaffected, while the cytoplasm and nucleus of columnar epithelium may swell after contact with the drug, and then shrink in a few seconds. Local application of policresulen does not produce toxicity.
Toxicity Studying
More than 50 years of clinical experience has proved that the local use of policresulen is non-toxic.
Acute toxicity: The LD50 of mice was 360mg/kg after intravenous administration and 2400mg/kg after oral administration. The LD50 of rats was 400mg/kg intravenously and 3500mg/kg orally. The LD50 of mice is 200 times of the therapeutic dose of human beings, and the LD50 of rats is 300 times of the therapeutic dose of human beings.
Chronic toxicity: Rats and dogs were given 40 times and 9 times of the human treatment dose for 3 months, no related toxic effect was found.
The skin tolerance test of policresulen was carried out on the back of hair removing rats. In the first 10 days of the 14 day observation, the application of different concentrations of policresulen (4%, 11% and 36%) only caused temporary skin redness, which lasted until the third application at most.
Reproductive toxicity: The study on pregnant rats and rabbits shows that there was no embryotoxicity or teratogenicity effect on animals. teratogenicity
Mutagenicity/carcinogenicity: there is no relevant study on the carcinogenesis of this product. Ames test proves that policresulen has no mutagenic effect there is no relevant research on the carcinogenesis of this product. Ames test proves that policresulen has no mutagenicity effects. Although there is no research report on carcinogenesis of this product, no mutagenic or carcinogenic effect has been found in clinical application for many years.
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WARNINGS
Please read the instruction carefully and use the product under the advice of doctor
Warning: during pregnancy, especially in the last three months of pregnancy, any treatment of the cervix should not be used, while the treatment of the vagina and its surrounding areas can only be used when absolutely necessary.
- ACTIVE INGREDIENT
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Content of Labeling
Instruction for Usage of Policresulen Vaginal Suppository
Please read the instruction carefully and use the product under the advice of doctor
Warning: during pregnancy, especially in the last three months of pregnancy, any treatment of the cervix should not be used, while the treatment of the vagina and its surrounding areas can only be used when absolutely necessary.
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INGREDIENTS AND APPEARANCE
JUJIAFENHUANGQUAN YINDAOSHUAN
policresulen vaginal suppository suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 84149-0102 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLICRESULEN (UNII: 6I19M5GB0G) (POLICRESULEN - UNII:6I19M5GB0G) POLICRESULEN 1 g in 90 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 84149-0102-3 5 mg in 1 BOTTLE; Type 0: Not a Combination Product 03/06/2024 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/06/2024 Labeler - Heilongjiang Tianlong Pharmaceutical Co Ltd (527931986) Registrant - Heilongjiang Tianlong Pharmaceutical Co Ltd (527931986) Establishment Name Address ID/FEI Business Operations Heilongjiang Tianlong Pharmaceutical Co Ltd 527931986 manufacture(84149-0102)
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