Brand Name
Natroba
Generic Name
Spinosad
View Brand Information FDA approval date: January 25, 2011
Classification: Pediculicide
Form: Suspension
What is Natroba (Spinosad)?
NATROBA is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older.
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Brand Information
Natroba (spinosad)
1DOSAGE FORMS AND STRENGTHS
Topical suspension: 0.9% w/w; each gram contains 9 mg of spinosad in a viscous, slightly opaque (white soft particles may be visible), light orange-colored suspension in 120 mL bottles.
2CONTRAINDICATIONS
None.
3OVERDOSAGE
No specific antidotes for spinosad overdosage are known. If oral ingestion occurs, contact Poison Control (1-800-222-1222) for latest recommendations and seek medical attention immediately.
4DESCRIPTION
NATROBA (spinosad) is a slightly opaque, light orange-colored, viscous topical suspension.
NATROBA is a pediculicide and scabicide. Spinosad, the active ingredient, is derived from the fermentation of a soil actinomycete bacterium,
Spinosad is a mixture of spinosyn A and spinosyn D in a ratio of approximately 5 to 1 (spinosyn A to spinosyn D).
Spinosyn A: The chemical name is: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,a5-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alpha-L-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-, (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-
Spinosyn D: The chemical name is: 1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alpha-L-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aSR,5aS,5bS,9S,13S,14R,16aS,16bS)-
NATROBA contains 9 mg spinosad per gram in a vehicle consisting of Benzyl Alcohol, Butylated Hydroxytoluene, Ceteareth-20, Cetearyl Alcohol, FD&C Yellow #6, Hexylene Glycol, Hydroxyethyl Cellulose, Isopropyl Alcohol, Propylene Glycol, Stearalkonium Chloride, Water, Hydrochloric acid (HCl) as pH adjuster.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
NATROBA (spinosad) topical suspension, 0.9% w/w; each gram contains 9 mg of spinosad in a slightly opaque (white soft particles may be visible), light orange-colored, viscous liquid, supplied in 4 oz (120 mL) high density polyethylene (HDPE) bottles. NDC 84635-929-04
6PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information)
Important Administration Instructions
Instruct the patient to:
- Shake bottle well immediately prior to application.
- Do not swallow.
- Avoid contact with eyes. If NATROBA gets in or near the eyes, rinse thoroughly with water.
- Apply NATROBA on pediatric patient only under direct supervision of an adult.
- If skin/scalp irritation occurs after use, contact your physician
Head Lice Infestation Treatment
- Apply NATROBA only on dry scalp and dry scalp hair.
- Repeat treatment only if live lice are seen seven (7) days after first treatment.
- Wash hands after applying NATROBA.
Scabies Infestation Treatment
- Apply NATROBA 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 it 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.
- Wash your hands after applying NATROBA to someone else.
- For breastfeeding women, remove NATROBA from the breast with soap and water before breastfeeding to avoid direct infant exposure to NATROBA
7Instructions for Use
Before you use NATROBA, it is important that you read this Instructions for Use. Be sure that you read, understand, and follow this Instructions for Use so that you use NATROBA the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use NATROBA.
Important information:
- Your hair and scalp must be
- For very thick, medium length hair or long hair, an entire bottle (120mL) of NATROBA may be needed to cover the scalp and hair. Less NATROBA may be needed for shorter, thinner hair.
How to apply NATROBA to your scalp and hair:
If you see live lice on your scalp or hair one week (7 days), after your first treatment, repeat the steps above.
How do I stop the spread of lice?
To help prevent the spread of lice from one person to another, here are some steps you can take:
- Avoid direct head-to-head contact with anyone known to have live, crawling lice.
- Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
- Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.
- After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
- Machine-wash or dry-clean any bedding, towels and clothing used by anyone having lice. Machine-wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.
- Wash personal items such as combs, brushes, and hair clips in hot water.
Distributed by: Cipher Pharmaceuticals US LLC, Carmel, IN 46032
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Revised: 6/2025
8Instructions for Use
Before you use NATROBA, it is important that you read this Instructions for Use. Be sure that you read, understand, and follow this Instructions for Use so that you use NATROBA the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use NATROBA.
How to apply NATROBA to your body:
How do I stop the spread of scabies?
To help prevent the spread of scabies from one person to another, here are some steps you can take:
- Get household members checked by their healthcare provider.
- Avoid direct body-to-body contact with anyone known to have scabies, including sexual partners.
- Do not share clothing, towels, bedding or linens with anyone else. The scabies mite can live in bedding, pillows, and carpets that have recently been used by someone with scabies.
- Machine-wash or dry clean any bedding, clothing and towels that you have used anytime during the three days before treatment by washing in hot water and drying in a hot dryer, or by sealing in a plastic bag for at least 72 hours. Machine-wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.
Distributed by: Cipher Pharmaceuticals US LLC, Carmel, IN 46032
NAT-PI-003
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Issued: 6/2025
9PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NDC 84635-929-04
120 mL
Rx only
Natroba™
For topical use only
