TaxTMI 
TaxTMI 
2005 (1) TMI 237
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....pical use only Description Nizral Shampoo 2% contains the synthetic broad spectrum antifungal agent Ketoconazole. One ml contains 20 mg Ketoconazole. Properties Pharmacodynamics Keotocnazole, a synthetic imidazole dioxolane derivative has a potent antifungal activity against dermatophytes, such as Trichophyton sp. Epidermophyton sp. Microsporum sp. and yeasts, such as candida sp. and Malassezia furfur (Pityrosporum ovale). Ketoconazole shampoo rapidly relieves scaling and pruritus, which are usually associated with pityriasis versicolor seborrhoeic dermatitis and pityriasis capitis (dandruff). Pharmacokinetics Percutaneous absorption of Ketoconazole shampoo is negligible since blood levels cannot be detected, even after chronic use. Systemic effects, therefore, are not expected. Indications Treatment and prophylaxis of infections in which the yeast pityrosporum is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff). Contra-indications Known hypersensitivity to Ketoconazole or the excipient. Warnings and Precautions To prevent a rebound effect after stopping a prolonged treatment with to....
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....tions, and that you should check with your doctor for any further information you may require. What is dandruff? Dandruff is a disorder affecting the hairy scalp. Hence, no dandruff can exist without hair. It is characterized by two major symptoms - scaling and itching. Scaling takes the form of white, transparent flakes of varying size, depending on the stage of the disease. Particularly on dark clothes, the flakes are conspicuous, which can be rather embarrassing to the person involved. The itching can be so intense that - mostly unconsciously - one starts to scratch one's head as a result of which even more flakes fall on the clothing. Some people have been suffering from persistent dandruff for years. In others, it flares up periodically. The incidence seems to increase during the winter months. It would be a mistake to assume that dandruff is synonymous with poor or inadequate hygiene. Even people excessively concerned with personal hygiene may be affected by dandruff. What triggers dandruff? Medical science has recently succeeded in pinpointing the cause of dandruff. The scoundrel is a single celled organism, a kind of fungus with the scientific name Pityrosporum ....
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.... Product literature (ii) Remington Pharmaceutical Sciences 1990 (iii) Martindale Extra Pharmacopeia (iv) Indian Pharmacopeia 1996 (v) The United States Pharmacopeia, The National Formulary 1995 (vi) Article of Mycoses (vii) Keotoconazole in Seborrhoeic Dermatitis & Dandruff-A Review (viii) Article by Johan McGrath & G.M. Murphy - The control of Seborrhoeic Dermatitis and Dandruff by Antipityrosporal Drugs. (ix) Article by H. Dobrev and L. Zissova - Effect of Ketoconazole 2% Shampoo on scalp Sebum level in Patients with Seborrhoeic Dermatitis. (x) Article by Danby et al - Ketoconazole 2% versus Selenium Sulfide 2.5% Shampoo. (xi) Affidavits (xii) Order dated 10-4-1996 passed by Assistant Commissioner of Central Excise, P....
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....diseases. The Commissioner has negatived the same and has taken a view that the product is essentially a preparation for use on hair/scalp and not used as a medicine although it is not disputed that it is manufactured under a drug licence/permission granted by the Drug Controller of India and Food and Drug Administration and sold on prescription of a Registered Medical Practitioner through a retail pharmacist only. 5.We have carefully considered the submissions made by the learned Counsel and the learned DR. We find from the extracted literature that the item comprises of 20 mg Ketoconazole in one ml and the pamphlet clearly indicates that it is for the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. The pamphlet claims that the item is used for treatment and prophylaxis of infections in which the yeast pityrosporum is involved such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff). The procedure for treatment and the adverse reactions on such treatment due to overdose is also stated in the pamphlet. The Apex court, in the case of Muller & Phipps (India) Ltd. v. CCE - 2004 (167) E.L.T. 347 (S.C.) has clear....