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U.S. Department of Health and Human Services

Safety

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Lindane (gamma-hexachlorocyclohexane)

Audience: Primary Care providers, Pharmacists, and consumers

FDA issued a Public Health Advisory concerning the use of topical formulations of Lindane Lotion and Lindane Shampoo for the treatment of scabies and lice. A boxed warning emphasizes that it is a second-line treatment, updates information about its potential risks, especially in children and adults weighing less than 110 pounds, and reminds practitioners that reapplication of Lindane Lotion or Lindane Shampoo is not the appropriate treatment, if itching continues after the single treatment.

A Medication Guide, designed to inform patients of the risks of Lindane products and provide instructions for appropriate use of the drugs, must now be dispensed by the pharmacist with each new prescription.

[March 28, 2003 - Public Health Advisory - FDA]