there were few adverse events reported in the phase iii clinical studies. the most commonly occurring adverse events included application-site erythema (redness of the skin) which occurred in 3% of the natroba™ patients (vs. 7% of permethrin), ocular erythema (redness and irritation of the eyes) which occurred in 2% of the natroba™ patients (vs. 3% of permethrin) and application-site irritation which occurred in 1% of natroba™ patients (vs. 2% permethrin). although adverse event rates were low for both products, application site redness occurred significantly less frequently in patients treated with natroba™ than in patients treated with permethrin (p = 0.007).
natroba™ topical suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.
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. most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).
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