FDA.reportPublic FDA data

LIENDREX

Manufacturer
Menper Distributors Inc. | Weeks & Leo Co., Inc.
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:08:18

Label at a glance#

ProductLIENDREX
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

PYRETHINS 0.30%

PIPERONYL BUTOXIDE 4%

OTC - PURPOSE SECTION

PURPOSE

LICE TREATMENT

INDICATIONS & USAGE SECTION

USES: FOR THE TREATMENT OF HEAD, BODY, PUBIC (CRAB) LICE.

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY.

CONTRAINDICATIONS SECTION

ALLERGY ALERT: USE WITH CAUTION ON PERSONS WITH ALLERGIC TO RAGWEED.

OTC - DO NOT USE SECTION

DO NOT USE

  • NEAR OR PERMIT CONTACT WITH EYES OR MUCOUS MEMBRANES, SUCH AS INSIDE THE NOSE, MOUTH, OR VAGINA AS IRRITATION MAY OCCURE.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

  • KEEP OUT OF EYES WHEN RINSING HAIR.
  • CLOSE EYES TIGHTLY AND DO NOT OPEN UNTIL PRODUCT IS RINSED OUT.
  • PROTECT EYES WITH WASHCLOTH, TOWEL OR OTHER SUITABLE MATERIAL OR BY SIMILAR METHOD.
  • IF PRODUCT GETS INTO EYES, IMMEDIATELY FLUSH WITH WATER.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF

  • SKIN IRRITATION OR INFECTION IS PRESENT OR DEVELOPS.
  • INFESTED EYEBROWS OR EYELASHES OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

IMPORTANT: READ WARNINGS AND OTHER INFORMATION BEFORE USING.

  • SHAKE WELL BEFORE USING.
  • USE ON DRY HAIR.
  • APPLY TO AFFECTED AREA UNTIL ALL HAIR IS THOROUGHLY WET WITH PRODUCT.
  • ALLOW PRODUCT TO REMAIN ON FOR 10 MINUTES BUT NO LONGER.
  • ADD SUFFICIENT WARM WATER TO FORM A LATHER AND SHAMPOO AS USUAL.
  • RINSE THOROUGHLY.
  • A FINE TOOTH COMB OR SPECIAL LICE/NIT-REMOVAL COMB MAY BE USED TO HELP REMOVE DEAD LICE AND THEIR EGGS (NITS) FROM HAIR.
  • A SECOND TREATMENT MUST BE DONE IN 7 TO 10 DAYS TO KILL ANY NEWLY HATCHED LICE.

OTHER SAFETY INFORMATION

OTHER INFORMATION

  • STORAGE: PROTECT FROM FREEZING AND EXCESSIVE HEAT.
  • DO NOT REUSE ORIGINAL CONTAINER.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS

WATER, PEG-80 SORBITAN LAURATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 80, SODIUM TRIDECETH SULFATE, SODIUM LAUROAMPHOACETATE, SODIUM LAURETH-13 CARBOXYLATE, CITRIC ACID AND TETRASODIUM EDTA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Linendrex Label ArtworkLinendrex Label Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372905piperonyl butoxide 4 % / pyrethrins 0.3 % Medicated ShampooPSN3
1372905piperonyl butoxide 40 MG/ML / pyrethrins 3 MG/ML Medicated ShampooSCD3
1372905piperonyl butoxide 4 % / pyrethrins 0.3 % Medicated ShampooSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-308-042020-01-31C16284748780-19d75b9d0-df5a-f424-e053-dadaa90a57ceLiendrex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-308-04LIENDREX120 mL in 1 BOTTLESHAMPOO1203

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PIPERONYL BUTOXIDEACTIVE INGREDIENTLWK91TU9AH1
PYRETHRUM EXTRACTACTIVE INGREDIENTZUM06L90GV1
PIPERONYL BUTOXIDEACTIVE MOIETYLWK91TU9AH1
PYRETHRUM EXTRACTACTIVE MOIETYZUM06L90GV1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
PEG-20 SORBITAN ISOSTEARATEINACTIVE INGREDIENTX958PZJ9ON1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SODIUM LAURETH-13 CARBOXYLATEINACTIVE INGREDIENT795TQP16551
SODIUM LAUROAMPHOACETATEINACTIVE INGREDIENTSLK428451L1
SODIUM TRIDECETH SULFATEINACTIVE INGREDIENTE827ILX3311
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-30853145-308-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PEG-20 SORBITAN ISOSTEARATEX958PZJ9ONIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM TRIDECETH SULFATEE827ILX331IACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
SODIUM LAURETH-13 CARBOXYLATE795TQP1655IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE SODIUMMP1J8420LUIACT
PIPERONYL BUTOXIDELWK91TU9AHACTIB
PYRETHRUM EXTRACTZUM06L90GVACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEG-20 SORBITAN ISOSTEARATEPEG-20 SORBITAN ISOSTEARATEX958PZJ9ONCREAM / TOPICAL6 %w/wExact identifier — unii+route
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSYSTEM / TOPICAL28 mgExact identifier — unii+route
14 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii+route
14 equally ranked IID candidates
PEG-20 SORBITAN ISOSTEARATEPEG-20 SORBITAN ISOSTEARATEX958PZJ9ONCREAM / TOPICAL6 %w/wExact identifier — unii+route
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HEMULSION / TOPICAL34050 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HEMULSION / TOPICAL34050 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route
14 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSYSTEM / TOPICAL28 mgExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii+route
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HOINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
14 equally ranked IID candidates

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
LIENDREXPYRETHRUM EXTRACT, PIPERONYL BUTOXIDEMenper Distributors Inc.65f86a0d-0cf7-42f6-84de-4dc9e7791aba2025-07-22WarningsExact identifier
ndc (package): 53145-308-04
ndc (product): 53145-308
ndc11 (package): 53145030804
spl id: 3a8ad090-e1c5-7ea7-e063-6394a90a6ffc
spl set id: 65f86a0d-0cf7-42f6-84de-4dc9e7791aba

Reported adverse events (FAERS/openFDA)#

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