Natroba

Natroba is an FDA-registered drug product whose active ingredient is SPINOSAD. It is labelled by ParaPRO LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 52246-929, application NDA022408, label effective 20210428. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SPINOSAD are most often described in connection with: topical treatment, head lice, infestations adult, pediatric patients, hot water, months age, natroba indicated, older adjunctive. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE NATROBA is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. ( 1.1 ) NATROBA is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older, ( 1.2 ) 1.1 Head Lice Infestations NATROBA TM is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. Adjunctive Measures for Head Lice Infestations NATROBA 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. 1.2 Scabies Infestations NATROBA is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. Adjunctive Measures for Scabies Infestations Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.

2 DOSAGE AND ADMINISTRATION • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) • Treatment of head lice infestations ( 2.2 ): o Shake bottle well o Apply a sufficient amount to cover dry scalp, then apply to dry hair o Rinse off with warm water after 10 minutes o Repeat treatment only if live lice are seen 7 days after first treatment • Treatment of scabies infestations ( 2.3 ): o Shake bottle well o Apply product to skin by rubbing it in to completely cover the body from the neck down to the soles of the feet o Patients with balding scalp should also apply product to the scalp, hairline, temples, and forehead o Allow to absorb in the skin and dry for 10 minutes before getting dressed o Leave on the skin for at least 6 hours before showering or bathing 2.1 Important Administration Instructions For topical use only. NATROBA is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. If NATROBA gets in or near the eyes, rinse thoroughly with water. 2.2 Treatment of Head Lice Infestations Shake bottle well. Apply a sufficient amount of NATROBA to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off with warm water. Wash hands after use. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Apply NATROBA on pediatric patient only under direct supervision of an adult [see Warnings and Precautions ( 5.1 )] . 2.3 Treatment of Scabies Infestations Shake bottle well. Apply a sufficient amount of NATROBA to skin to completely cover the body from the neck to the toes (including the soles of the feet). For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead. Allow to absorb into the skin and dry for 10 minutes before getting dressed. Leave on the skin for at least 6 hours before showering or bathing. Apply NATROBA on pediatric patient only under direct supervision of an adult.

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. ( 6.1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ParaPRO, LLC at 1-855-628-7622 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Head Lice Infestations NATROBA was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; Table 1 presents selected adverse events, regardless of relationship to NATROBA, that occurred in at least 1% of subjects. Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation Signs Natroba (N=552) Permethrin 1% (N=457) Application site erythema 17 (3%) 31(7%) Ocular erythema 12 (2%) 15 (3%) Application site irritation 5 (1%) 7 (2%) Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin. Scabies Infestations NATROBA was studied in three randomized, double-blind, vehicle-controlled trials (Trial 1, Trial 2, and Trial 3) in 592 subjects with scabies infestation, of which 165 were ages 4-17 and 427 were adults. Subjects received a single application of NATROBA to the skin from the neck to the soles of the feet, which was washed off after a minimum of 6 hours. Table 2 presents adverse reactions related to NATROBA treatment that occurred in at least 1% of subjects. Table 2: Adverse Reactions Occurring in at least 1% of Subjects with Scabies Infestation (Trials 1, 2 and 3) Signs Natroba (N=322) Vehicle (N=270) Application site irritation* 8 (3%) 0 (0%) Dry skin 6 (2%) 0 (0%) *Application site irritation also includes application site pain and burning sensation.

What is Natroba used for?
1 INDICATIONS AND USAGE NATROBA is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. ( 1.1 ) NATROBA is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older, ( 1.2 ) 1.1 Head Lice Infestations NATROBA TM is indicated for the topical …

Who makes Natroba?
ParaPRO LLC is the labeler of record for Natroba.

What form does Natroba come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Natroba prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Natroba been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.