See Supplemental Patient Information
- Indicated for topical use only; not for oral, ophthalmic, or intravaginal use
- Spinosad topical suspension contains benzyl alcohol and is not recommended in neonates and infants <6 months of age
- Systemic absorption of benzyl alcohol may cause serious adverse reactions and death in neonates and low birth-weight infants
Supplemental Patient Information
- Advise patients to shake bottle well right before use
- Instruct patients to use the product only on dry scalp and dry scalp hair
Pregnancy Category:B
Breastfeeding: Data not available on the clinical use of spinosad during breastfeeding. Because it is not absorbed systemically following topical application, it should not be present in breast milk. Product contains benzyl alcohol, which may be absorbed systemically through the skin. High doses of benzyl alcohol may be toxic to neonates, but it is unlikely that doses this high reach breastmilk. Nursing women concerned about benzyl alcohol may pump and discard breastmilk for 8 hrs. Apply water-miscible cream or gel products to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 3 August 2011). As per manufacturer's data, product contains benzyl alcohol, which may be absorbed systemically through the skin, and the amount of benzyl alcohol excreted in human milk is unknown. Nursing women may choose to pump and discard breast milk for 8 hrs. Caution should be exercised while administering to nursing women.
4 yrs
