Head Lice
Scabies

Important Safety Information
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Important Safety Information

Head Lice

Indication
Natroba^™ (Spinosad) Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients six (6) months of age and older.

Adjunctive Measures
Natroba^™ (Spinosad) Topical Suspension should be used in the context of an overall lice management program:

Wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels
Wash personal care items such as combs, brushes, and hair clips in hot water
A fine-tooth comb or special nit comb may be used to remove dead lice and nits

Important Safety Information
Natroba^™ (Spinosad) Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Intravenous administration of benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

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.

Scabies

Indication
Natroba^™ (Spinosad) Topical Suspension 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 Natroba^™ (Spinosad) Topical Suspension.

Important Safety Information
Natroba^™ (Spinosad) Topical Suspension contains benzyl alcohol and is not recommended for use in pediatric patients below the age of 4 years. The safety and effectiveness of Natroba^™ (Spinosad) Topical Suspension 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 for Natroba^™ (Spinosad)

Head Lice

Indication
Natroba^™ (Spinosad) Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients six (6) months of age and older.

Adjunctive Measures
Natroba^™ (Spinosad) Topical Suspension should be used in the context of an overall lice management program:

Wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels
Wash personal care items such as combs, brushes, and hair clips in hot water
A fine-tooth comb or special nit comb may be used to remove dead lice and nits

Important Safety Information
Natroba^™ (Spinosad) Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Intravenous administration of benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

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.

Scabies

Indication
Natroba^™ (Spinosad) Topical Suspension 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 Natroba^™ (Spinosad) Topical Suspension.

Important Safety Information
Natroba^™ (Spinosad) Topical Suspension contains benzyl alcohol and is not recommended for use in pediatric patients below the age of 4 years. The safety and effectiveness of Natroba^™ (Spinosad) Topical Suspension 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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