Danil

Manufacturer
Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.
Effective date
2025-02-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:55:29

Label at a glance#

ProductDanil
Active ingredientKETOCONAZOLE, CLOBETASOL PROPIONATE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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 SECTION

There is no any special warning.

INACTIVE INGREDIENT SECTION

Clobetasol propionate 0.25mg

INDICATIONS & USAGE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - PURPOSE SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Ketoconazole 15mg
Clobetasol Propionate 0.25mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Content of LablingContent of LablingCOMPOUND KETOCONAZOLE SOLUTION FOR SCALP DISORDERS

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOBETASOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84277-5665-3Danil100 g in 1 TUBESOLUTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84277-5665DANIL (DANIL COMPOUND KETOCONAZOLE SOLUTION FOR SCALP DISORDERS.) SOLUTION [JIANGSU CHENPAI BOND PHARMACEUTICAL CO.,LTD.]41 package rows20250221_177cf130-60df-a67c-e063-6294a90ab657.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84277-566584277-5665-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2e5ad164-898f-f276-e063-6394a90ade14177cf130-60df-a67c-e063-6294a90ab6572025-02-17WarningsExact identifier
spl id: 2e5ad164-898f-f276-e063-6394a90ade14
spl set id: 177cf130-60df-a67c-e063-6294a90ab657

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.