Rx Item-Spinosad 0.9% Suspension 120Ml By Allegis Pharma

NATROBA- spinosad suspension
ParaPRO LLC
1 INDICATIONS AND USAGE
1.1 Indication

NATROBA (spinosad) Topical Suspension is indicated for the topical treatment of head lice infestation in patients six (6) months of age and older.
1.2 Adjunctive Measures

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-tooth comb or special nit comb may be used to remove dead lice and nits.

2 DOSAGE AND ADMINISTRATION

For topical use only. NATROBA Topical Suspension is not for oral, ophthalmic, or intravaginal use.

Shake bottle well. Apply sufficient NATROBA Topical Suspension 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 NATROBA Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.
3 DOSAGE FORMS AND STRENGTHS

0.9%, viscous, slightly opaque, light orange-colored suspension in 120 mL bottles.
4 CONTRAINDICATIONS

None.
5 WARNINGS AND PRECAUTIONS
5.1 Benzyl Alcohol Toxicity

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 [See Use in Specific Populations (8.4)].
6 ADVERSE REACTIONS
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.
DESCRIPTION

NATROBA (spinosad) Topical Suspension, is a slightly opaque, light orange colored, viscous topical suspension.
Spinosad, the active ingredient, is derived from the fermentation of a soil actinomycete bacterium, Saccharopolyspora spinosa.Spinosad is a mixture of spinosyn A and spinosyn D in a ratio of approximately 5 to 1 (spinosyn A to spinosyn D).
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action

Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice become paralyzed and die.

RX ITEM-Spinosad 0.9% Suspension 120Ml B
NDC 28595-0570-04 UPC/GTIN No.0-28595-57004-3 Mfg.Part No.57004

Spinosad 0.9% Suspension 120Ml By Allegi
BRAND: SPINOSAD NDC: 28595-0570-04,28595057004 UPC: 0-28595-57004-3,28595570043

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