Spinosad Topical Suspension Head Lice and Scabies
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Important Safety Information

Indication
Spinosad Topical Suspension 0.9% is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients four (4) years of age and older.

Adjunctive Measures

  • Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.
  • If any member of a household presents with scabies, all household members should be treated with Spinosad Topical Suspension 0.9%.

Important Safety Information
Spinosad Topical Suspension 0.9% contains benzyl alcohol and is not recommended for use in pediatric patients below the age of 4 years. The safety and effectiveness of Spinosad Topical Suspension 0.9% have not been established in pediatric patients less than 4 years of age with scabies infestation. Most common adverse events were: application site irritation (3%)* and dry skin (2%).

*Application site irritation also includes application site pain and burning sensation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information

Indication
Spinosad Topical Suspension 0.9% is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients four (4) years of age and older.

Adjunctive Measures

  • Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.
  • If any member of a household presents with scabies, all household members should be treated with Spinosad Topical Suspension 0.9%.

Important Safety Information
Spinosad Topical Suspension 0.9% contains benzyl alcohol and is not recommended for use in pediatric patients below the age of 4 years. The safety and effectiveness of Spinosad Topical Suspension 0.9% have not been established in pediatric patients less than 4 years of age with scabies infestation. Most common adverse events were: application site irritation (3%)* and dry skin (2%).

*Application site irritation also includes application site pain and burning sensation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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