Spinosad 9 mg/mL
spinosad · SUSPENSION · ParaPRO LLC
Spinosad is a prescription topical suspension used to treat head lice infestations. This medication belongs to a class of drugs called pediculicides, which work to kill lice.
Key Facts
- Brand Name
- Spinosad
- Generic Name
- spinosad
- NDC Code (Product)
52246-570- Manufacturer
- ParaPRO LLC
- Strength
- 9 mg/mL
- Dosage Form
- SUSPENSION
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022408
- Drug Class
- Pediculicide [EPC]
- Marketing Start
- 01/29/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Spinosad Topical Suspension 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 ) Spinosad Topical Suspension 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 Spinosad Topical Suspension 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 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. 1.2 Scabies Infestations Spinosad Topical Suspension 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,…
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. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. If Spinosad Topical Suspension 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 Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair leng…
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 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 Spinosad Topical Suspension 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 Spinosad Topical Suspension, 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 Spinosad (N=552) Permethrin 1% (N=457) Application site erythema 17 (3%) 31(7%) Ocular erythema 12 (2%) 15 (3%) …
Frequently Asked Questions
What is Spinosad used for?
Spinosad is a prescription topical suspension used to treat head lice infestations. This medication belongs to a class of drugs called pediculicides, which work to kill lice.
Is Spinosad a controlled substance?
Spinosad is not classified as a controlled substance by the DEA.
What is the generic name for Spinosad?
The generic name for Spinosad is spinosad. There are 2 other brand versions of spinosad.
What is the NDC code for Spinosad 9 mg/mL?
The NDC (National Drug Code) for Spinosad 9 mg/mL is 52246-570, listed by ParaPRO LLC.