INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo OROCHLOR (solution)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

OROCHLOR (solution)

COMPOSITION:
Each 100 mL of solution contains:
  Benzocaine 266,667 mg
  Chlorhexidine gluconate solution 20% 1 mL
  Alcohol 96% (as preservative) 20% v/v
PHARMACOLOGICAL CLASSIFICATION:
A.16.3 Surface anaesthetics.

PHARMACOLOGICAL ACTION:
Chlorhexidine is a bactericidal cationic antiseptic. It acts by destroying the cell membrane and precipitating the cell cytoplasm. It has been shown that chlorhexidine binds on to the hydroxyapatite of tooth enamel, onto the pellicle of the tooth surface and on to salivary mucins. It slowly desorbs from these sites to exert a prolonged bactericidal effect for several hours.

Benzocaine has mild local anaesthetic properties.

INDICATIONS:
Orochlor
solution is indicated for temporary relief of pain and discomfort in sore throats due to cold (and accompanying tickling cough). It is also recommended for minor mouth irritations.

CONTRA-INDICATIONS:
Orochlor
solution is contra-indicated in patients with a hypersensitivity to local anaesthetics.

DOSAGE AND DIRECTIONS FOR USE:
Use 15 - 30 mL (3 - 6 medicine measuresful) undiluted, or diluted with a small quantity of warm water and thoroughly rinse the mouth for about one minute every 3 - 4 hours as needed.
Depending on the location of the pain, the solution should be swished around the mouth and/or used as a gargle. It should not be swallowed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local skin sensitivity reactions may occur. Prolonged use may cause discolouration of the teeth.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Methaemoglobinaemia has occurred in infants after absorption of benzocaine. Excitation with subsequent depression of the central nervous system. Treatment is symptomatic.

CONDITIONS OF REGISTRATION:
None

IDENTIFICATION:
Clear, orange red viscous liquid.

PRESENTATION:
Amber bottles containing 100 mL, 350 mL and 500 mL solution.

STORAGE INSTRUCTIONS:
Store below 25° C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
P/16.3/41

NAME AND BUSINESS ADDRESS OF APPLICANT:
Triomed (Pty) Limited,
Building No. 3, Parc Du Cap,
Corner Mispel Road and Willie van Schoor Road, Belville, 7530.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26.10.1989

       
M987

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