FDA.reportPublic FDA data

Herklin

Manufacturer
MarcusUSA | Weeks & Leo Co.Inc
Effective date
2017-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:55

Label at a glance#

ProductHerklin
Active ingredientPiperonyl butoxide, Pyrethrum extract
Label structure9 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 back 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 app...

Storage and handling

do not freeze store at controlled room temperature, 20 °C to 25 °C (68 °F to 77 °F) Questions or comments call (515) 276-1586 see package insert for additional information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Piperonyl butoxide 4%Lice treatment
Pyrethrum extract (equivalent to 0.33% pyrethrins)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

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 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 back 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 thoroughly 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 strand 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

STORAGE AND HANDLING SECTION

  • do not freeze
  • store at controlled room temperature, 20 °C to 25 °C (68 °F to 77 °F)

OTC - QUESTIONS SECTION

  • Questions or comments call (515) 276-1586
  • 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

SPL UNCLASSIFIED SECTION

Distributed by: MarcasUSA, LLC
El Segundo CA, 90245

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

• PROUDLY SERVING FAMILIES FOR •
38
YEARS

HERKLIN®
LICE TREATMENT

Piperonyl butoxide 4%
Pyrethrum extract (0.33% pyrethrins)

Kills Lice &
Eliminates Nits*

Effective & safe for ages 2+

NEED HELP? •
Toll
Free
(844) HERKLIN
(437-5546)

INCLUDES:
Shampoo, Lice
& Nit Comb

LICE COMB INCLUDED

8 fl oz (236 mL)

*Proper use of nit comb removes nits.

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75940-171-04Herklin236 mL in 1 BOTTLESHAMPOO2361
75940-171-04Herklin1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75940-171HERKLIN (PIPERONYL BUTOXIDE AND PYRETHRUM EXTRACT) SHAMPOO [MARCUSUSA]1Current NDC, Legacy NDC, 2 package rows20171108_908f9a80-d1cf-448e-8e35-e4dc856e0e99.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75940-17175940-171-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Piperonyl butoxideLWK91TU9AHACTIB
Pyrethrum extractZUM06L90GVACTIB
PEG-25 hydrogenated castor oil0ZNO9PJJ9JIACT
polyquaternium-10 (125 MPA.S at 2%)L45WU8S981IACT
alcohol3K9958V90MIACT
water059QF0KO0RIACT

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
HerklinPIPERONYL BUTOXIDE AND PYRETHRUM EXTRACTMarcusUSA908f9a80-d1cf-448e-8e35-e4dc856e0e992017-11-07WarningsExact identifier
ndc (package): 75940-171-04
ndc (product): 75940-171
ndc11 (package): 75940017104
spl id: 6c7c7bed-7527-44ce-9616-f155db2e4753
spl set id: 908f9a80-d1cf-448e-8e35-e4dc856e0e99

Reported adverse events (FAERS/openFDA)#

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