Label: DANIL- danil compound ketoconazole solution for scalp disorders. solution
- NDC Code(s): 84277-5665-3
- Packager: Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 16, 2024
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DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: External use only. Apply about 5ml of DANIL solution to moist hair, massage it gently to let the solution contact with the scalp thoroughly, after 3~5 minutes, rinse cleanly with water. For treatment purpose , the DANIL solution should be used twice/thrice a week continuously for 2~4 weeks; for prevention purpose, it should be used once every one or two weeks.
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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KEEP OUT OF REACH OF CHILDREN
PRECAUTIONS: 1. Avoid contact with the eyes and other mucous membranes(oral and nasal). 2. Stop and clean the drug, if burning sensation and red swelling of the skin appears. Consult with the doctor, if necessary. 3. Consult with the doctor or pharmacist if it is necessary to use DANIL for more than 4 weeks continuously. 4. You can use other hair-care product if your hair is dry after using DANIL. 5. Infants and children should use it with cautions. 6. It is contraindicated for individuals who have known or suspected hypersensitivity to any of its ingredients. It should be used with cautions in individuals with allergic constitution. 7. Do not use it if the appearance of the solution is changed. 8. Keep it out of the reach of children. 9. Children should use it under the supervision of adults. 10. Consult a doctor or pharmacist before use DANIL, if you are using any other medicines at the same time.
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PURPOSE
PHARMACOLOGICAL ACTION: In vitro, DANIL solution exhibits a potent antimycotic activity. In vivo studies in animal patterns infected with superficial fungi, it is shown that DANIL solution has an excellent therapeutic effect, especially for that caused by Pityrosporum oval. Combined with Clobetasol propionate, a potent anti-inflammatory and anti-pruritic topical corticosteroid agent, DANIL solution has the actions of anti-bacterial, anti-inflammatory, anti-allergic, anti-dandruff and anti-pruritus. Clinical trial reports that the DANIL solution has proved to be more effective and more rapid in treatment of dandruff and seborrheic dermatitis on the scalp than the single Ketoconazole lotion. Animal acute toxicity test and toxicity test for local application and clinical trial indicated that the DANIL solution is safe for use, no allergic or irritant reaction is found.
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DANIL
danil compound ketoconazole solution for scalp disorders. solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84277-5665 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 15 mg in 1 g CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) EDETATE DISODIUM (UNII: 7FLD91C86K) COCONUT OIL GLYCERETH-8 ESTERS (UNII: 9V234MGT7F) PEG-14 1-((METHYLPHENYL)ETHYL)PHENYL ETHER AMMONIUM SULFATE (UNII: S4S9783N13) DIETHYLENE GLYCOL DISTEARATE (UNII: 617Q4OD69O) AA-1 CATION (UNII: 52UXI5SZHT) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) EOSIN B (UNII: OMS4XQD1T0) GLYCEROL FORMAL (UNII: 3L7GR2604E) 2-(ETHYLSULFONYL)ETHANOL (UNII: 95YYW1049K) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84277-5665-3 100 g in 1 TUBE; 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(84277-5665)
COMPOUND KETOCONAZOLE SOLUTION FOR SCALP DISORDERS