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HSA Approval

DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION

SIN08671P

DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION

DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION

April 24, 1996

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantINOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Licence HolderINOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

MOUTHWASH

**How to use this medicine?** Difflam®-C Solution should generally be used undiluted, but if stinging occurs it may be diluted with water. The solution should be expelled from the mouth after use. Uninterrupted treatment should not exceed seven days. **Adults** When used as a gargle, 15mL should be gargled for at least 30 seconds at 1½ to 3 hourly intervals, as needed. When used as a rinse for oral lesions, 15mL should be held in the mouth and swished around for at least 30 seconds. Repeat usage every 1½ to 3 hours throughout the day. If used as an alternative to usual oral hygiene procedures, Difflam®-C Solution should be swished around in the mouth for at least a minute. Difflam®-C Solution is best used after brushing the teeth to minimise chlorhexidine-induced discolouration. Difflam®-C Solution is not intended for prolonged use except under dental or medical supervision. **Children** 5–15mL as a gargle if able to do so, or as an oral rinse. Difflam®-C Solution is not recommended for children under 6 years of age.

ORAL

Medical Information

**What is this medicine used for?** Benzydamine in Difflam®-C Solution helps to relieve painful conditions of the mouth and throat including sore throat, pharyngitis, tonsilitis, mouth ulcers, swelling, redness and inflammatory conditions, pain following mouth or throat surgery and pain following dental procedures. Chlorhexidine in Difflam®-C Solution helps to reduce the development of plaque and gingivitis during the period of treatment when the usual oral hygiene measures are interrupted. Difflam®-C is not intended for prolonged use except under dental or medical supervision.

**Do not use this medicine if** You are allergic to benzydamine or to any of the components of the product. Chlorhexidine may cause a severe allergic reaction. Symptoms of allergic reaction may include wheezing/difficulty breathing, facial swelling, hives, rash. If any allergic reaction occurs, stop use and seek medical help immediately.

A01AD02

benzydamine

Manufacturer Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Ensign Laboratories Pty Ltd

Active Ingredients

BENZYDAMINE HCl

22.5 mg/15 ml

Benzydamine

CHLORHEXIDINE GLUCONATE

18 mg/15 ml

Chlorhexidine

Documents

Patient Information Leaflets

Difflam C Anti-Inflammatory Antiseptic Solution PIL.pdf

Approved: October 20, 2022

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DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION - HSA Approval | MedPath