Product Details

Rufenac Gel 1%+++

Diclofenac Sodium (Diclofenac Diethylamine); Methyl salicylate; Menthol
1.16%; 3%; 2%
Gel

ROA

Topical

Applicant Name

Shalina Healthcare Nigeria Limited

NRN

A4-6124

Status

Active


Composition

Rufenac Gel contains: Diclofenac Diehthylammonium Salt 1.16% w/w equivalent to Diclofenac Sodium BP 1.0% w/w, Methyl Salicylate BP 3.0% w/w and Menthol BP 2.0% w/w Excipients: Acrypol 980 In-House, Acrysol 140 USP/NF, Disodium Edetate BP, Methyl Hydroxy Benzoate (Methyl Paraben) BP, Propyl Hydroxy Benzoate (Propyl Paraben) BP, Triethanolamine BP and Purified water (q.s) BP  

ATC Code

M01AB55  

Product Category

Drugs

Marketing Category

Over-the-counter (OTC)  

Packsize

1 x 30 g (in Aluminium tube)  

Product Description

Topical gel 86 RNW-PP-375327 RUFENAC GEL 1% Diclofenac Diehthylammonium salt 1.16% w/w equivalent to Diclofenac sodium BP 1.0% w/w, Methyl Salicylate BP 3.0% w/w & Menthol BP 2.0% w/w. Diclofenac Dimethylammonium salt 1.16% w/w equivalent to Diiclofenac Sodium BP 1.0% w/w, Methyl Salicylate Bp 3.0% w/w & menthol BP 2.0& w/w. Excipients- Disodium Edetate BP, Methyl Hydroxy Benzoate BP, Propyl Hydroxy Benzoate BP, Triethanolamine BP, Polyoxyl 40 Hydrogenated Castor oil USNF, Carbomer 980 USNF A4-6124 Drugs Imported Products 1*30grams Over The Counter (OTC) 10/19/2023 SHALINA HEALTHCARE NIGERIA LIMITED, FATAI ATERE WAY, MATORI MUSHIN LAGOS LAGOS GOLPALDAS VISRAM & CO., LTD., PLOT NO.A590/591, T.T.C INDUSTRIAL AREA,MIDC MAHAPE, NAVI MUMBAI, THANE 400701 MAHARASHTRA STATE, INDIA., India

Manufacturer Name

GOLPALDAS VISRAM & CO., LTD

Manufacturer Country

INDIA  

Approval Date

2024-03-27  

Expiry Date

2029-03-26