Product Details

Betasol Plus Cream##

Clobetasol; Ketoconazole; Neomycin
0.25mg; 10mg; 5000IU
Cream

ROA

Topical

Applicant Name

Shalina Healthcare Nigeria Limited

NRN

B4-9264

Status

Active


Composition

Each 15 g tube contains: Clobetasol Propionate USP 3.75 mg, Ketoconazole (micronized) USP 150 mg, Neomycin Sulphate BP 141.8 mg Each 30 g tube contains: Clobetasol Propionate USP 7.5 mg, Ketoconazole (micronized) USP 300 mg, Neomycin Sulphate BP 283.6 mg Excipients: Clobetasol Propionate USP, Ketoconazole USP, Neomycin Sulfate BP, Cetomacrogol 1000 BP, Cetostearyl Alcohol BP, Methyl Hydroxy Benzoate BP, Propyl Hydroxy Benzoate BP, White Soft Paraffin BP (White Petroleum Jelly), Parachloro Meta Cresol (Chlorocresol) BP, Propylene Glycol BP, Anhydrous Sodium Sulphite BP, Sodium Dihydrogen Phosphate Dihydrate BP, Carrot Fragrance 120314 IH, Purified Water q.s. BP  

ATC Code

D07CD01  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 x 30 g,1 x 15 g (in Alu tubes)  

Product Description

Cream 43 RNW-PP-339620 BETASOL PLUS CREAM CLOBETASOL PROPIONATE, KETOCONAZOLE, NEOMYCIN SULPHATE Clobetasol Propionate USP 0.25mg, Ketoconazole USP 10mg, Neomycin Sulfate BP 5000IU (EXCIPIENTS: Cetomacrogol 1000 BP, Cetostearyl Alcohol BP, Methyl Hydroxy Benzoate BP, Propyl Hydroxy Benzoate BP, White Soft Paraffin BP (White Petroleum Jelly), Parachloro Meta Cresol (Chlorocresol) BP, Propylene Glycol BP, Anhydrous Sodium Sulphite BP, Sodium Dihydrogen Phosphate Dihydrate BP, Carrot Fragrance 120314 IH, Purified Water (q.s.) BP) B4-9264 Drugs Imported Products 1X30G,1X15G Prescription Only Medicine (POM) 7/5/2023 SHALINA HEALTHCARE NIGERIA LIMITED, 19 Fatai Atere Way, Matori, Mushin Lagos 18183973 theophilus.adimoha@shalina.com Shalina Laboratories Pvt Ltd. , Plot No E-2 & E-3, MIDC Jejuri, Tal Purandar, Pune 412303 Maharashtra State, India, India

Manufacturer Name

Shalina Laboratories Pvt Ltd

Manufacturer Country

INDIA  

Approval Date

2024-02-28  

Expiry Date

2029-02-27