The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Chenpai Bond Pharmaceutical Co.,ltd. for the product Danil (NDC 84277-5666). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
There is no any special warning.
Clobetasol propionate 0.25mg
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.
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.
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 Ingredients:
Ketoconazole 15mg
Clobetasol Propionate 0.25mg
Content Of Labling (Danil)
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