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

Logo ICY HOT Ointment
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ICY HOT Ointment

COMPOSITION:
Each 100 g of ICY HOT contains 29,02 g methyl salicylate and 7,65 g menthol.

PHARMACOLOGICAL CLASSIFICATION:
A 13.7 Counterirritants

PHARMACOLOGICAL ACTION:
Methyl salicylate relieves pain by a counterirritant action. When rubbed on the skin it produces mild irritation and is absorbed to an appreciable extent.

INDICATIONS:
ICY HOT is indicated for temporary relief of minor aches and pains of muscle and/or joints such as those associated with strains, arthritis, simple backache, sprains etc.

CONTRA-INDICATIONS:
Allergy to salicylate or sensitivity to any of the components. Application to broken skin or raw surfaces.

DOSAGE AND DIRECTIONS FOR USE:
For external use only. ICY HOT is applied liberally to the painful area, and massaged until absorbed. This treatment is repeated as necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Use only as directed. Keep away from children to avoid accidental poisoning. Keep away from eyes, mucous membranes and broken or irritated skin. Do not swallow. If skin irritation develops, discontinue use. Consult physician if pain lasts 10 days or more, if redness is present, or before using on children under 12 years of age. Therapy might be hazardous for patients with impaired kidney or liver function or for smaller children. Menthol may give rise to hypersensitivity reactions including contact dermatitis (inflammation of the skin).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Ingestion of relatively small amounts of methyl salicylate may cause severe poisoning and death. Symptoms of poisoning are nausea, vomiting, acidosis, pulmonary oedema (excessive fluid accumulation in the lungs), pneumonia (lung infection), convulsions (seizures, fits) and death. Although rapidly absorbed through the skin when applied cutaneously, its gastro-intestinal absorption may be delayed many hours and therefore gastric lavage (stomach wash-out) should be performed even in cases of poisoning that are seen late.
Systemic poisoning can occur from its application to large areas of the skin. Treatment of acute poisoning may be aimed at preventing absorption, treatment of the fluid and acid base balance and other electrolyte problems, or promoting elimination of the drug.

IDENTIFICATION:
White to off-white ointment.

PRESENTATION:
ICY HOT is available in 50 g and 100 g aluminium tubes and in 50 g and 100 g tubs.

STORAGE INSTRUCTIONS:
Ensure cap is tightly closed. ICY HOT should be stored in a dry place, below 30°C.
Keep out of reach of children.

REGISTRATION NUMBER:
L/13.7/75

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 February 1996

Updated on this site: February 2005
Source: Pharmaceutical Industry

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