FDA.reportPublic FDA data

HERKLIN Lice Treatment

Manufacturer
Estrella Brands, LLC
Effective date
2019-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:02

Label at a glance#

ProductHERKLIN Lice Treatment
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure7 sections

Indications and uses

treats head, pubic (crab), and body lice

Dosage and administration

Important: Read warnings before use adults and children 2 years and over: Inspect check each household member with a magnifying glass in bright light for lice/nits (eggs) look for tiny nits near scalp, beginning at bact of neck and behind ears examine small sections of hair at a time unlike dandruff which moves when touched, nits stick to the hair if either lice or nits are found, treat with this product  Treat ap...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Piperonyl butoxide 4% 

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purposes

OTC - PURPOSE SECTION

Lice treatment

Uses

INDICATIONS & USAGE SECTION

treats head, pubic (crab), and body lice

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • near eyes
  • inside nose, mouth, or vagina
  • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

  • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

When using this product

OTC - WHEN USING SECTION

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets in eyes, flush with water right away
  • scalp itching or redness may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

  • Important: Read warnings before use
  • adults and children 2 years and over: Inspect
  • check each household member with a magnifying glass in bright light for lice/nits (eggs)
  • look for tiny nits near scalp, beginning at bact of neck and behind ears
  • examine small sections of hair at a time
  • unlike dandruff which moves when touched, nits stick to the hair
  • if either lice or nits are found, treat with this product 

Treat

  • apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck.
  • allow product to remain for 10 minutes, but no longer
  • use warm water to form a lather, shampoo, then thorughly rinse
  • for head lice, towel dry hair and comb out tangles

Remove lice and their eggs (nits)

  • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
  • hair should remain slightly damp while removing nits
  • if hair dries during combing, dampen slightly with water
  • for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours.
  • lift a 1- to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
  • pin back each strandd of hair after combing
  • Clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
  • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
  • check daily for any lice/nits that you missed
  • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
  • if infestation continues, see a doctor for other treatments

children under 2 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • do not freeze
  • store at controlled room temperature. 20 °C to 25 °C (68 °F to 77 °F)
  • Questions or comments call (XXX) XXX-XXXX
  • see package insert for additional information

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

HERKLIN Lice Treatment Kit (72902-002-08)   |   HERKLIN Lice Treatment Shampoo 8oz/236ml (72902-000-08)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1988409Herklin 4 % / 0.33 % Medicated ShampooPSN2
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN2
1988409piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo [Herklin]SBD2
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD2
1988409Herklin (piperonyl butoxide 4 % / pyrethrins 0.33 % ) Medicated ShampooSY2
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72902-002-082021-01-29C16284748780-1ba0f9c33-1a69-a910-e053-dadaa90a0b85HERKLIN Lice Treatment Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72902-000-08HERKLIN Lice Treatment1 in 1 CARTONSHAMPOO40 mg in 1mL2
72902-000-08HERKLIN Lice Treatment236 mL in 1 BOTTLESHAMPOO236 mL3.3 mg in 1mL2
72902-002-08HERKLIN Lice Treatment1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72902-000HERKLIN LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM) KIT [ESTRELLA BRANDS, LLC]2Unmatched20190401_9187ae41-db5e-4c69-8f16-d047cd522274.zip
72902-002HERKLIN LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM) KIT [ESTRELLA BRANDS, LLC]2Legacy NDC, 3 package rows20190401_9187ae41-db5e-4c69-8f16-d047cd522274.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72902-00272902-002-08
72902-00072902-000-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-25 HYDROGENATED CASTOR OIL0ZNO9PJJ9JIACT
WATER059QF0KO0RIACT
PIPERONYL BUTOXIDELWK91TU9AHACTIB
PYRETHRUM EXTRACTZUM06L90GVACTIB

Source Document#

Source XML

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
822ad468-e532-0e56-e053-2a91aa0a649e9187ae41-db5e-4c69-8f16-d047cd5222742019-02-18WarningsExact identifier
spl id: 822ad468-e532-0e56-e053-2a91aa0a649e
spl set id: 9187ae41-db5e-4c69-8f16-d047cd522274

Reported adverse events (FAERS/openFDA)#

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