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HSA Approval

ORA-SED JEL

SIN04948P

ORA-SED JEL

ORA-SED JEL

July 16, 1990

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Regulatory Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Therapeutic

General Sale List

Formulation Information

GEL

**Suggested dose, dosage regimen and method of application:** For infants above 4 months apply Ora-Sed Jel every three hours at bedtime. Massage well into gums. For the treatment of mouth ulcers wipe surface free of mucus before application. Avoid prolonged treatment in infants.

ORAL

Medical Information

**Indication:** Transient mouth ulcers, denture discomfort, infant teething pain, sore gums.

**Contraindications:** Not to be used in infants where viral infection is suspected. **Warnings/reminders/instructions to users:** This product should not be given to patients known to be hypersensitive to salicylate.

A01AD11

various

Manufacturer Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

HAMILTON PHARMACEUTICAL PTY LTD

Active Ingredients

BENZALKONIUM CHLORIDE

0.1 mg/ml

Benzalkonium

CHOLINE SALICYLATE

0.09 ml/ml

Choline salicylate

Documents

Package Inserts

Ora-Sed Jel PI.pdf

Approved: November 7, 2006

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