Do not apply to individuals with extensive dermatitis or to those with acutely inflamed areas or open, weeping lesions. May cause temporary skin irritaion usually at the start of therapy aand when applied to broken or inflamed skin. Use in pregnancy or lactation has not been established and the drug should only be used if, in the opinion of a physician, the potential benefits to the mother outweigh the potential harm to fetus or infant. Efficacy and safety have not been established for use in children under 12 years of age. If sensitivity or severe irritation develops with the use of the drug, discontinue treatment and consult with a physician.
Irritation is increased when the drug is applied to broken or irritated skin.
The drug may cause important adverse reactions, including allergies, or interacts with other drugs, foods, or disease states that cannot be adequately addressed through product labelling. The drug is a new ingredient for self-medication and monitoring by the pharmacist is necessary to facilitate observation and reporting of any unexpected event.