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

Logo DEEP HEAT LINIMENT

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DEEP HEAT LINIMENT

COMPOSITION:
Each 10 g contains:
Methyl Salicylate   20,00 g
Menthol   6,00 g

PHARMACOLOGICAL CLASSIFICATION:
A 13.6 Dermatological preparations: Rubefacients.

PHARMACOLOGICAL ACTION:
Rubefacient and counter irritant.

INDICATIONS:
Deep Heat Liniment is indicated for the temporary relief of minor pain and stiffness of rheumatism and muscle soreness.

CONTRA-INDICATIONS:
Hypersensitivity to the ingredients.

WARNINGS:
Do not apply to broken skin or raw areas.

DOSAGE AND DIRECTIONS FOR USE:
Massage Deep Heat Liniment into affected area until it is absorbed by the skin. Repeat three times a day, as required. For faster results soak the affected area in hot water, pat dry with towel, then massage in the liniment.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Use only as directed
a) Side effects: Skin sensitivity may develop. Should this occur, discontinue immediately. Due to the presence of menthol, contact dermatitis may occur. Symptoms of urticaria, flushing and headache may also occur.
b) Precautions: For external use only. Avoid contact with the eyes. Exercise care with sensitive skins. Do not use on children under 5 years of age. Do not apply to nostrils of infants. Wash hands after use.

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 swallowing, the following symptoms may appear: Indigestion of relatively small amounts of methyl salicylate may cause severe poisoning and death.
The methyl salicylate content may give rise to irritation of the gastric mucosa and resultant dyspepsia, erosion, ulceration, haematesis and melaena.
Mild symptoms of intoxication could include dizziness, tinnitus, sweating, nausea, 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 whilst cases of asphyxiation have been reported in infants following local application of menthol.

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

IDENTIFICATION:
A smooth cream-coloured liniment with the odour of menthol and methyl salicylate.

PRESENTATION:
White flint glass bottles containing either 75 mL or 150 mL.

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

REGISTRATION NUMBER:
Q/13.6/177.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
HYDE PHARMACEUTICALS (Pty) Limited
Co Reg. No. 72/09391/07
80 Bonza Bay Road
Beacon Bay
5241

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 November 1990

CODE 308004                B23
        LH&SEL - J2756 K92

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