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

Logo SOLARUB (OINTMENT)

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

SOLARUB (OINTMENT)

COMPOSITION:
Each 100 g contains:       
Methyl Salicylate 10 g

PHARMACOLOGICAL CLASSIFICATION:
A 13.6        Rubefacients

INDICATIONS:
For the temporary relief from minor pain and stiffness of rheumatism and muscle soreness

CONTRA-INDICATIONS:
Hypersensitivity to methyl salicylate. Do not apply to broken skin and excessively raw areas. Do not use on children under 5 years of age.

WARNINGS:
For external use only. Avoid contact with eyes. Exercise care with sensitive skins

PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Massage into the affected area three times daily as required. Wash hands after use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Skin sensitivity may develop. Should this occur discontinue use immediately. Symptoms of flushing and headache may also occur. Urticaria and angioneurotic oedema, in persons sensitive to aspirin, may occur following local application.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic poisoning may occur from application to large areas of the skin. In cases of accidental ingestion, the following symptoms may appear; the methyl salicylate may give rise to irritation of the gastric mucosa and resultant dyspepsia, erosion, ulceration, haematemesis and melaena.
Mild symptoms of intoxication could include dizziness, tinnitus, sweating, nausea and vomiting and mental confusion.
More serious signs of toxicity include hyperventilation, fever, ketosis and respiratory alkalosis and metabolic acidosis. Coma, cardiovascular collapse and respiratory failure may result.
Ingestion of relatively small amounts of methyl salicylate may cause severe poisoning and death.

TREATMENT IN CAS EOF ACCIDENTAL SWALLOWING:
Empty the stomach by emesis or aspiration or gastric lavage with 5% sodium bicarbonate solution.
Treatment of poisoning is symptomatic and supportive.

IDENTIFICATION:
Yellowish, unctuous ointment with a distinctive methyl salicylate odour.

PRESENTATION:
25 g and 50 g aluminium tubes and plastic containers
500 g plastic jar

STORAGE INSTRUCTIONS:
Keep tightly closed, protect from light. Store below 25ºC.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/13.6/108

NAME AND BUSINESS ADDRESS OF APPLICANT:
GULF DRUG COMPANY (PTY) LTD
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE
4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 April 2002

New addition to this site: July 2010
Source: Pharmaceutical Industry

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