Nix

Manufacturer
Central Texas Community Health Centers
Effective date
2019-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:12

Label at a glance#

ProductNix
Active ingredientPERMETHRIN
Label structure11 sections

Dosage and administration

Inspect all household members should be checked by another person for lice and/or nits (eggs) use a magnifying glass in bright light to help you see the lice and nits (eggs) use a tool, such as a comb or two unsharpened pencils to lift and part the hair look for tiny nits near the scalp, beginning at the back of the neck and behind the ears small sections of hair (1-2 inches wide) should be examined at a time unli...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each fluid ounce)

OTC - ACTIVE INGREDIENT SECTION

Permethrin 280 mg (1%)

Purpose

OTC - PURPOSE SECTION

Lice treatment

Use

INDICATIONS & USAGE SECTION

treats head lice

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 months of age
  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes. See your doctor.

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

OTC - WHEN USING SECTION

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into the eyes, immediately flush with large amounts of water
  • scalp itching or redness may occur

Stop use and see a doctor if

OTC - STOP USE SECTION

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Inspect

  • all household members should be checked by another person for lice and/or nits (eggs)
  • use a magnifying glass in bright light to help you see the lice and nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
  • small sections of hair (1-2 inches wide) should be examined at a time
  • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
  • if either lice or nits (eggs) are found, treat with Nix® Creme Rinse

Treat

  • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix®. Rinse with water.
  • towel dry hair so it is damp but not wet
  • shake the bottle of Nix® well
  • completely saturate the hair and scalp with Nix®. Begin to apply Nix® behind the ears and at the back of the neck.
  • keep Nix® out of the eyes. Protect the eyes with a washcloth or towel.
  • leave Nix® on the hair for 10 minutes, but no longer
  • rinse with warm water
  • towel dry hair and comb out tangles
  • if live lice are seen seven days or more after the first treatment, a second treatment should be given

Remove Lice/Nits

  • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
  • use the nit comb provided and make sure the hair remains slightly damp while removing nits
  • if the hair dries during combing, dampen it slightly with water
  • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
  • start at the top of the head on the section you have picked
  • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
  • use clips to pin back each strand of hair after you have combed out the nits
  • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
  • after combing, recheck the entire head for nits and repeat combing if necessary
  • check the affected head daily to remove any nits that you might have missed

Other information

SPL UNCLASSIFIED SECTION

  • read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

balsam canada, cetyl alcohol, citric acid, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethylcellulose, polyoxyethylene 10 cetyl ether, propylene glycol, stearalkonium chloride, water, isopropyl alcohol, methylparaben, and propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-LICE LINE (1-888-542-3546), Monday to Friday, 9 AM - 5 PM EST

Distributed by:
INSIGHT Pharmaceuticals LLC.
Tarrytown, NY 10591

A Prestige Brands Company

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 76413-358

NDC: 76413-358-01 1 mL in a CARTON

NIX (PERMETHRIN) SHAMPOO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
763066Nix Cream Rinse 1 % Medicated ShampooPSN2
250387permethrin 1 % Medicated ShampooPSN2
763066permethrin 10 MG/ML Medicated Shampoo [Nix Cream Rinse]SBD2
250387permethrin 10 MG/ML Medicated ShampooSCD2
763066Nix Cream Rinse 1 % Medicated ShampooSY2
763066Nix Cream Rinse 10 MG/ML Medicated ShampooSY2
250387permethrin 1 % Medicated ShampooSY2
250387permethrin 1 % Topical LotionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PERMETHRIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-358-012021-01-29C16284748780-1ba0f9c33-4ce8-a910-e053-dadaa90a0b85NIX®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-358-01Nix1 mL in 1 CARTONSHAMPOO12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-358NIX (PERMETHRIN) SHAMPOO [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]2Legacy NDC, 1 package rows20190116_ad967f76-6fda-4ac9-a71f-d0603a6ed71e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63736-024-03ML - Milliliter63736-024edae0d8b-ee49-4c7a-9d75-27b6627413e912017-10-13
63736-024-04ML - Milliliter63736-024dadced74-ab25-4fa4-af43-6eae607d479e12019-04-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-35876413-358-01
63736-024

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019918-001NIXPERMETHRIN1%LOTION / TOPICALRLD, RS1990-05-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0284e616aacf4f…
2026-08-18 06:07:402026-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
94262aba-87d5-495c-997e-9380d95f2787ad967f76-6fda-4ac9-a71f-d0603a6ed71e2019-01-15WarningsExact identifier
spl id: 94262aba-87d5-495c-997e-9380d95f2787
spl set id: ad967f76-6fda-4ac9-a71f-d0603a6ed71e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.