These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

IMPORTANT NOTE: Salicylic acid - Extended and prolonged use over large areas of the body, especially in children, pregnant or nursing mothers, and those patients and people suffering with significant renal or hepatic impairment, could result in salicylism. Combined use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic acid gel should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate.

Pregnancy and breastfeeding - This product may be absorbed through the mother's skin. Salicylic acid has not been studied in pregnant women. However, studies in animals have shown that salicylic acid causes birth defects when given orally in doses about 6 times the highest dose recommended for topical use in humans. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant, especially if you will be using salicylic acid on large areas of your body.

Children - Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children.