INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MENTHOLATUM BALM NF (OINTMENT)

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

MENTHOLATUM BALM NF (OINTMENT)

COMPOSITION:
Each 1 g ointment contains:

Racemic Camphor		100 mg
Levomenthol		16,6 mg

PHARMACOLOGICAL CLASSIFICATION:
A 10.2.2 Medicines acting on respiratory system. Other.

PHARMACOLOGICAL ACTION:
Nasal decongestant

INDICATIONS:
Relieves blocked nose.
A chestrub for the relief of congestive symptoms associated with sinusitis, head colds, nasal catarrh and nasal congestion.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

WARNINGS:
Do not apply to raw areas.
Do not apply in or near the eyes or the nostrils of infants or toddlers.

DOSAGE AND DIRECTIONS FOR USE:
FOR EXTERNAL USE ONLY
Dissolve one teaspoonful (5 mL) of MENTHOLATUM BALM NF in a jug of boiling water and inhale the vapour. OR : Apply to the chest and massage gently when necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Menthol may cause sensitivity reactions including contact dermatitis.
There have been reports of apnoea and instant collapse in infants following the application of menthol or camphor to their nostrils. Avoid contact with eyes. Exercise care with sensitive skins.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions"
Treatment is symptomatic and supportive.
Symptoms of overdosage after accidental ingestion include epigastric colic, headache, feeling of warmth, muscle twiching and weakness, miosis, tachycardia, epileptiform convulsions, delirium and coma. In event of accidental ingestion consult your doctor or take the patient immediately to the nearest hospital

IDENTIFICATION:
A pale yellow ointment with odour of menthol and camphor.

PRESENTATION:
Clear plastic jars with while screw on lids containing 50 g of the ointment.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
29/10.2.2/0658

NAME AND BUSINESS ADDRESS OF APPLICANT:
Mentholatum South Africa (Pty) Ltd
80 Bonza Bay Road
BEACON BAY
5241

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1995
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