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

Logo MENTHOLATUM DEEP HEAT* SPRAY

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

MENTHOLATUM DEEP HEAT* SPRAY

COMPOSITION:
Each 100 g contains:
Methyl Nicotinate 1,59 g; Monoglycol Salicylate 4,95 g; Ethyl Salicylate 4,95 g; Methyl Salicylate 0,99 g.

PHARMACOLOGICAL CLASSIFICATION:
A.13.6 Rubefacients.

INDICATIONS:
Indicated for pain relief and provides temporary relief from the minor pain and stiffness of rheumatism and muscle soreness.

CONTRA-INDICATIONS:
Hypersensitivity to the ingredients.

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

DOSAGE AND DIRECTIONS FOR USE:
Shake can before use. Spray onto the parts affected when necessary, before or after exercise. Pointing the spray aperture towards the area of pain, holding can about 15 cm from the skin, press the button and spray in 2-3 short bursts. Massage is not required.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Use only as directed.
SIDE-EFFECTS: Skin sensitivity may develop. Should this occur, discontinue immediately Symptoms of urticaria, flushing and headache may also occur.
PRECAUTIONS: FOR EXTERNAL USE ONLY. Protect the face when spraying around the neck and shoulders. Avoid contact with eyes and inhalation. Always use sparingly as over-use may cause discomfort, particularly in persons with sensitive skins. Exercise care with sensitive skins. Do not use on children under 5 years of age. If symptoms persist, consult your doctor.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Ingestion of relatively small amounts of methyl salicylate may cause severe poisoning and death. The methyl salicylate may give rise to irritation of the gastric mucosa and dispepsia, erosion, ulceration, haematemesis and melaena.
Systematic poisoning may occur from application to large areas of the skin. 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. Treatment is symptomatic and supportive.

IDENTIFICATION:
Pressurised aerosol multi-dose dispenser for administration to human beings as a topical spray. The spray is a clear liquid with a characteristic smell of Methyl Salicylate.

PRESENTATION:
Pressurised aerosol multi-dose dispenser with contents of 110 g / 150 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from direct sunlight. Do not pierce or burn, even when empty. Do not spray on a naked flame or any incandescent material.

REGISTRATION NUMBER:
Q/13.6/264.

NAME AND ADDRESS OF THE APPLICANT:
MENTHOLATUM SOUTH AFRICA (PTY) LTD
Owners of the Mentholatum Deep Heat Trademark:
Mentholatum Co. Ltd. - East Kilbride - Scotland.

DATE OF PUBLICATION:
October 1983

CODE 308041        A23
                LH&SEL-K10206 F95

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