DANIL- danil compound ketoconazole solution for scalp disorders. solution

Danil by

Drug Labeling and Warnings

Danil 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]

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

There is no any special warning.

INACTIVE INGREDIENT

Clobetasol propionate 0.25mg

INDICATIONS & USAGE

EXPIRATION DATE: Three years after the manufactured date. For external use only. Avoid contact with eyes. Keep out of reach of children. Do not exceed prescribed dose. Read package insert carefully before using.

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.

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

Active Ingredients:

Ketoconazole 15mg
Clobetasol Propionate 0.25mg

PRINCIPAL DISPLAY PANEL

COMPOUND KETOCONAZOLE SOLUTION FOR SCALP DISORDERS

INGREDIENTS AND APPEARANCE

DANIL 
danil compound ketoconazole solution for scalp disorders. solution

Product 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)