Approval date: January 10, 2023
Topical
Ketoconazole Ointment
Please read the instructions carefully and use under the supervision of a physician.
[Name of drug]
Generic Name: Ketoconazole Ointment
Hanyu Pinyin: Fufang Tongkangzuo Ruangao
[Ingredients]
This product is a compound preparation containing ketoconazole 10 mg and clobetasol propionate 0.5 mg per gram. The excipients are octadecanol, liquid paraffin, stearic acid, disodium edetate, triethanolamine, glycerol, ethyl hydroxybenzene, anhydrous sodium sulfite, dibutylhydroxytoluene, purified water.
[Properties]
This product is a white or off-white ointment in an emulsion base.
[Indications]
Used for ringworm, tinea cruris, tinea pedis, tinea cruris.
[Specifications]
1g: ketoconazole 10mg and clobetasol propionate 0.5mg.
[Usage and dosage]
For external use. Apply directly to the affected area twice a day.
[Adverse Reactions]
1. common erythema, burning, itching, tingling or other symptoms of irritation, folliculitis, skin atrophy and thinning, capillary dilatation, hyperpigmentation, and secondary infections.
2. Dry skin, hirsutism, atrophic lines, and increased susceptibility to infection are seen.
3. long-term use of the drug may cause hypercorticism, manifested as hirsutism, acne, full moon face, osteoporosis and other symptoms.
4. Occasionally, it can cause allergic dermatitis.
[Taboo]
1. It is prohibited for those who are allergic to this product.
2. Viral infections such as herpes and chickenpox are prohibited.
3. pediatric, pregnant and lactating women are prohibited.
[Caution]
1. avoid contact with eyes and other mucous membranes (such as mouth, nose, etc.); should not be used on the face, armpits, groin and vulva and other thin skin places.
2. Use with caution for those with allergies.
3. ringworm patients, do not wear tightly fitting underwear or chemical fiber underwear, it is appropriate to wear cotton loose underwear.
4. For patients with tinea pedis, dry the skin after bathing (especially the skin between the toes). It is advisable to wear cotton socks and change them every day. Shoes should be breathable.
5. the use of medication sites such as burning sensation, redness and swelling should be discontinued, and the local drug washed, serious cases should seek medical attention.
6. this product contains a strong corticosteroid clobetasol propionate, can not be long-term, large-scale application, and should not be used to seal the treatment.
[Drug interactions]
Drug interactions may occur if used concurrently with other medications, consult your physician or pharmacist for details.
[Pharmacological effects]
Ketoconazole contained in this product is an antifungal drug; clobetasol propionate is a glucocorticoid with strong anti-inflammatory and anti-allergic effects.
[Storage]
Keep away from light, airtight and at room temperature.
[Packaging]
Aluminum medicated ointment tubes: 10g per tube, 1 tube per box; 15g per tube, 1 tube per box.
[Effective Date]
24 months.
[Enforcement Standards]
ws1-xg-005-2001.
[Approval number]
National Drug Code: H20059966 ;
[Listed licensee] ;
Name：Zhejiang Fonow Medicine Co. Ltd.
Registered Address: No. 209 West Hulian Avenue, Dongyang City, China
Postal code: 322100
Phone number: 0579-86358015
Fax number: 0579-86358016
//shengyuell.com
[Manufacturer]
Name：Zhejiang Fonow Medicine Co. Ltd.
Registered Address: No. 209 West Hulian Avenue, Dongyang City, China
Postal code: 322100
Phone number: 0579-86358015
Fax number: 0579-86358016
//shengyuell.com