Natroba™ safety starts with a naturally occurring active ingredient.

Unlike the synthetic permethrin found in OTC treatments6, the active ingredient in Natroba™ is spinosad—derived from a naturally occurring soil microorganism.1

Spinosad Infographic

Mechanism of Action

Along with a highly sensitive and selective mechanism of action that differs from neurotoxic agents like permethrin and pyrethroids:

The active ingredient, spinosad, targets lice and nits right where they live–doesn’t go beyond the stratum corneum, before breaking down through desquamation;4

Spinosad, the active ingredient, breaks down through the natural desquamation process, with no systemic absorption even in patients as young as six (6) months of age;2,4

No evidence of neurotoxicity, developmental/reproductive toxicity, immunotoxicity, mutagenicity, or carcinogenicity from spinosad exposure.5

What the clinical trials revealed

Natroba™ demonstrated similar or lower treatment related AEs versus the leading OTC medication, Nix® (permethrin 1%).3

No systemic absorption
Spinosad, the active ingredient, was below the level of quantitation (3ng/mL), even in patients as young as six (6) months of age.4

No lab abnormalities
No clinically significant laboratory test results were reported for spinosad. A review of the individual and summary laboratory test results did not identify any safety signal.5

No toxicities
No evidence of neurotoxicity, developmental/reproductive toxicity, immunotoxicity, mutagenicity, or carcinogenicity from spinosad exposure.5

No environmental effects
EPA concludes reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to spinosad residues.5

chart-3
*Statistically significant (3.1% vs. 6.8%; p=0.0007)

Next: Learn how prior authorization helps ensure efficacy.

Nix® is a registered trademark of Prestige Brands, Inc.

 

References:

  1. Millar, N. S. & Denholm, I. Nicotinic acetylcholine receptors: targets for commercially important insecticides. Invert. Neurosci. 7, 53-66.
  2. Natroba Prescribing Information.
  3. Stough D, Shellabarger S, Quiring J, Gabrielsen A. Efficacy and safety of spinosad and permethrin crème rinses for pediculosis capitis (head lice). Pediatrics. 2009;124(3): e389-395.
  4. Data on file.
  5. Federal Register /Vol. 80, No. 248 /Monday, December 28, 2015 /Rules and Regulations.
  6. CDC-Headlice-Treatment-OTC Medications (8.18.2016). Retrieved from https://www.cdc.gov/parasites/lice/head/treatment.html

NAT-RRW9-001

Important Safety Information

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

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

Important Safety Information

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

Adjunctive Measures
Natroba™ 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-toothed comb or special nit comb may be used to remove dead lice and nits.

Important Safety Information
Natroba™ Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously. 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.