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Spinosad (Natroba): Uses, Side Effects and Dosage

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9 mg/mL
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Spinosad

What is Spinosad Topical Suspension?

Spinosad Topical Suspension is a prescription medicine used to treat head lice on the scalp and hair of adults and children 6 months of age and older.

It is not known if Spinosad Topical Suspension is safe and effective for children under 6 months of age.

See " How do I stop the spread of lice?" at the end of this leaflet for additional information on ways to stop the spread of lice.

Before you use Spinosad Topical Suspension, tell your healthcare provider about all of your medical conditions, including if you or your child:

  • have any skin conditions or sensitivities

  • are pregnant or plan to become pregnant. It is not known if Spinosad Topical Suspension can harm your unborn baby.

  • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with Spinosad Topical Suspension.

How should I use Spinosad Topical Suspension?

  • See the detailed " Instructions for Use" at the end of this leaflet.
  • Apply Spinosad Topical Suspension exactly as prescribed by your healthcare provider. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
  • Apply Spinosad Topical Suspension when your hair is dry. Do not wet your hair before applying Spinosad Topical Suspension.
  • It is important to apply enough Spinosad Topical Suspension to completely coat all of your hair and scalp. Leave Spinosad Topical Suspension on your hair and scalp for a full 10 minutes.
  • If live lice are seen one week (7 days) after you applied Spinosad Topical Suspension, you will need to apply Spinosad Topical Suspension again.
  • Because you need to completely cover all of the lice with Spinosad Topical Suspension, you may need help in applying Spinosad Topical Suspension to your scalp and hair.
  • Children will need an adult to apply Spinosad Topical Suspension for them.
  • Do not get Spinosad Topical Suspension into your eyes. If Spinosad Topical Suspension gets in your eye, rinse well with water right away.
  • If you have any scalp irritation after you apply Spinosad Topical Suspension, call your healthcare provider right away.
  • Wash your hands after you apply Spinosad Topical Suspension.
  • Do not swallow Spinosad Topical Suspension.If swallowed, call Poison Control at 1-800-222-1222 or go to the nearest emergency room right away.

What are the possible side effects of Spinosad Topical Suspension?

The most common side effects of Spinosad Topical Suspension includeredness where Spinosad Topical Suspension is applied and redness to eyes.

These are not all the possible side effects of Spinosad Topical Suspension.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Spinosad Topical Suspension?

  • Store Spinosad Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Spinosad Topical Suspension and all medicines out of the reach of children.

General information about the safe and effective use of Spinosad Topical Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Spinosad Topical Suspension for a condition for which it was not prescribed. Do not give Spinosad Topical Suspension to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Spinosad Topical Suspension that is written for health professionals.

What are the ingredients in Spinosad Topical Suspension?

Active ingredient:spinosad

Inactive ingredients: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.

Instructions for Use

Before you use Spinosad Topical Suspension, 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 Spinosad Topical Suspension the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use Spinosad Topical Suspension.

Important information:

  • Your hair and scalp must be drybefore applying Spinosad Topical Suspension.
  • For very thick, medium length hair or long hair, an entire bottle (120mL) of Spinosad Topical Suspension may be needed to cover the scalp and hair. Less Spinosad Topical Suspension may be needed for shorter, thinner hair.

How to apply Spinosad Topical Suspension to your scalp and hair:

Step 1
  • Shake Spinosad Topical Suspension bottle well right before use.
Step 2
  • Cover your face and eyes with a towel and keep your eyes closed tightly.
  • Apply Spinosad Topical Suspension directly to dryhair and scalp.
  • Completely cover the scalp and hair closest to the scalp first, and then apply outwards towards the ends of the hair.
  • It is important to apply enough Spinosad Topical Suspension to cover your entire scalp and hair so that all lice and eggs are exposed to Spinosad Topical Suspension.
Step 3
  • Allow Spinosad Topical Suspension to stay on your scalp and hair for 10 minutes. Use a timer or clock and start timing after you have completely covered your hair and scalp with Spinosad Topical Suspension.
  • Continue to keep eyes covered to prevent dripping into your eyes.
  • After 10 minutes, completely rinse Spinosad Topical Suspension from your hair and scalp with warm water.
  • You may use a fine-tooth comb to remove treated lice and nits from the hair and scalp, but combing is not required.
  • Wash your hands after applying Spinosad Topical Suspension.
  • It is okay to shampoo your hair any time after the treatment.

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

Patient Information for Scabies Treatment

Spinosad Topical Suspension

Important: For use on skin only. Do not get Spinosad Topical Suspension in your eyes, mouth, or vagina.

What is Spinosad Topical Suspension?

Spinosad Topical Suspension is a prescription medicine used to treat scabies in adults and children 4 years of age and older.

It is not known if Spinosad Topical Suspension is safe and effective in children under 4 years of age.

See " How do I stop the spread of scabies?" at the end of this leaflet.

Before you use Spinosad Topical Suspension, tell your healthcare provider about all of your medical conditions, including if you or your child:

  • have any skin conditions or sensitivities
  • are pregnant or plan to become pregnant. It is not known if Spinosad Topical Suspension can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Wash the breast area with soap and water to remove Spinosad Topical Suspension before breastfeeding to avoid exposure to your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Spinosad Topical Suspension.

How should I use Spinosad Topical Suspension?

  • See the detailed " Instructions for Use" at the end of this leaflet.
  • Apply Spinosad Topical Suspension exactly as prescribed by your healthcare provider. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
  • It is important to apply enough Spinosad Topical Suspension to completely cover your body from your neck to the soles of your feet. Make sure you apply to folds of skin, between fingers and toes, and under finger and toe nails.
  • If you are balding, apply Spinosad Topical Suspension to the scalp, hairline, temples, and forehead.
  • Wait a full 10 minutes to allow Spinosad Topical Suspension to soak into the skin and dry before getting dressed. Leave Spinosad Topical Suspension on the skin for at least 6 hours before showering or bathing.
  • Because you need to completely cover your body from the neck down with Spinosad Topical Suspension, you may need help in applying Spinosad Topical Suspension to ensure full coverage.
  • Children will need an adult to apply Spinosad Topical Suspension for them.
  • Do not get Spinosad Topical Suspension into your eyes. If Spinosad Topical Suspension gets in your eye, rinse well with water right away.
  • If you have any skin irritation after you apply Spinosad Topical Suspension, call your healthcare provider right away.
  • Wash your hands after applying Spinosad Topical Suspension to someone else.
  • Do not swallow Spinosad Topical Suspension.If swallowed, call Poison Control at 1-800-222-1222 or go to the nearest emergency room right away.

What are the possible side effects of Spinosad Topical Suspension?

The most common side effects of Spinosad Topical Suspension includeirritation (including pain and burning) at application sites and dry skin.

These are not all the possible side effects of Spinosad Topical Suspension.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Spinosad Topical Suspension?

  • Store Spinosad Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Spinosad Topical Suspension and all medicines out of the reach of children.

General information about the safe and effective use of Spinosad Topical Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Spinosad Topical Suspension for a condition for which it was not prescribed. Do not give Spinosad Topical Suspension to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Spinosad Topical Suspension that is written for health professionals.

What are the ingredients in Spinosad Topical Suspension?

Active ingredient: spinosad

Inactive ingredients: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.

Instructions for Use

Before you use Spinosad Topical Suspension, 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 Spinosad Topical Suspension the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use Spinosad Topical Suspension.

How to apply Spinosad Topical Suspension to your body:

Step 1
  • Shake the Spinosad Topical Suspension bottle well right before use.
Step 2
Figure AFigure BFigure C
  • Apply Spinosad Topical Suspension to the skin. (See Figure A)
  • Apply enough Spinosad Topical Suspension to completely cover your body from your neck to the soles of your feet. (See Figure B). Make sure you apply to folds of skin, between fingers and toes, and under finger and toe nails. (See Figure C)
  • If you are balding, you should also apply Spinosad Topical Suspension to the scalp, hairline, temples and forehead.
  • You may need help applying Spinosad Topical Suspension to ensure full coverage.
  • If you do not completely cover your body with Spinosad Topical Suspension, some scabies mites may escape treatment.
  • Wash your hands after applying Spinosad Topical Suspension to someone else.
Step 3
Figure DFigure EFigure F
  • Allow Spinosad Topical Suspension to soak into the skin and dry for 10 minutes. Use a timer or clock and start timing after you have completely covered your body with Spinosad Topical Suspension. (See Figure D)
  • After 10 minutes, you can get dressed. (See Figure E)
  • Wait at least 6 hours before showering or bathing. (See Figure F)

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

SPN-PI-004

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Issued: 6/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 022408 · View the label on DailyMed

Revision date stated in the text: June 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Spinosad

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Pediculicide
Active ingredient Spinosad 9 mg/mL
Dosage form Suspension
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) CIPHER
FDA approval NDA AUTHORIZED GENERIC 022408NDA authorized generic Approved January 18, 2011
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 3 labelers list this drug on DailyMed
Packages (NDC)
Package
9 mg/mL – 120 ml in 1 bottle, plastic / 1 in 1 carton NDC 84635-570-04

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.