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HSA Approval

DIFFLAM MOUTH GEL

SIN09963P

DIFFLAM MOUTH GEL

DIFFLAM MOUTH GEL

August 28, 1998

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Regulatory Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Therapeutic

Pharmacy Only

Formulation Information

GEL

**DOSAGE AND ADMINISTRATION** 1. Apply approximately 1 cm of gel with finger. 2. Gently massage into sore area. 3. Do not eat or drink for 15 minutes. 4. Apply every 2–3 hours up to a maximum of 12 times/day. **With Impaired Renal Function** Since absorbed benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with renal impairment. **With Impaired Liver Function** Since absorbed benzydamine is highly metabolised in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.

SUBMUCOSAL

Medical Information

**INDICATIONS** Temporarily relieves painful inflamed conditions of the mouth, including mouth and denture ulcers and sore gums.

**CONTRAINDICATIONS** Difflam Mouth Gel is contraindicated in patients with known hypersensitivity to benzydamine or cetylpyridinium chloride or to any of the components of the vehicle.

A01AD11

various

Manufacturer Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Ensign Laboratories Pty Ltd

Active Ingredients

BENZYDAMINE HCl

10 mg/g

Benzydamine

CETYLPYRIDINIUM CHLORIDE

1 mg/g

Documents

Patient Information Leaflets

PIL_Clean.pdf

Approved: November 19, 2018

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