Natroba 9 mg/mL
spinosad · SUSPENSION · Cipher Pharmaceuticals Inc.
Natroba is a prescription topical suspension used to treat head lice infestations. It contains spinosad, which is a pediculicide that kills lice and their eggs on contact.
Key Facts
- Brand Name
- Natroba
- Generic Name
- spinosad
- NDC Code (Product)
84635-929- Manufacturer
- Cipher Pharmaceuticals Inc.
- Strength
- 9 mg/mL
- Dosage Form
- SUSPENSION
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022408
- Drug Class
- Pediculicide [EPC]
- Marketing Start
- 01/25/2011
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Treatment of head lice infestations ( 2.2 ): Shake bottle well Apply a sufficient amount to cover dry scalp, then apply to dry hair Rinse off with warm water after 10 minutes Repeat treatment only if live lice are seen 7 days after first treatment Treatment of scabies infestations ( 2.3 ): Shake bottle well Apply product to skin by rubbing it in to completely cover the body from the neck down to the soles of the feet Patients with balding scalp should also apply product to the scalp, hairline, temples, and forehead Allow to absorb in the skin and dry for 10 minutes before getting dressed 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 scal…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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 Cipher Pharmaceuticals US 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 irrita…
Frequently Asked Questions
What is Natroba used for?
Natroba is a prescription topical suspension used to treat head lice infestations. It contains spinosad, which is a pediculicide that kills lice and their eggs on contact.
Is Natroba a controlled substance?
Natroba is not classified as a controlled substance by the DEA.
What is the generic name for Natroba?
The generic name for Natroba is spinosad. There are 3 other brand versions of spinosad.
What is the NDC code for Natroba 9 mg/mL?
The NDC (National Drug Code) for Natroba 9 mg/mL is 84635-929, listed by Cipher Pharmaceuticals Inc..