Herklin Lice Treatment

Manufacturer
MarcasUSA LLC | Weeks & Leo Co.Inc
Effective date
2018-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:17

Label at a glance#

ProductHerklin Lice Treatment
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure10 sections

Indications and uses

​ ​Uses treats head lice, pubic (crab) lice, 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, beginin 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 ap...

Storage and handling

do not freeze store at controlled room temperature, 20 °C to 25 ° C (68 ºF to 77 ºF) Questions or comments call (844) 437-5546 see package insert for additional information

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Piperonyl butoxide 4%.........................................................................Lice Treatment

Pyrethrum extract (equivalent to 0.33 % pyrethrins.................................Lice Treatment

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Treatment head, pubic (crab), and body lice

​Uses

INDICATIONS & USAGE SECTION

​​Uses treats head lice, pubic (crab) lice, 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 us 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 doctor if

OTC - STOP USE SECTION

  • breathing difficulty occurs
  • eye irrirtation 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, beginin 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.
  • life 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 froom coming back.
  • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
  • 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:​ aska doctor

​Other Information

STORAGE AND HANDLING SECTION

  • do not freeze
  • store at controlled room temperature, 20 °C to 25 ° C (68 ºF to 77 ºF)
  • Questions or comments call (844) 437-5546
  • see package insert for additional information

Consumer Information

SPL UNCLASSIFIED SECTION

Kills Lice & Eliminates Nits in 3 simple steps

​​​STEP 1: APPLY • APLIQUE

Apply shampoo ​on dry hair​​ for 10 minutes.

​Step 1Step 1

STEP 2: REMOVE • RETIRE

Remove lice and nits with comb provided.

Step 2Step 2

​STEP 3: REPEAT • REPITA

​Repeat treatment 1 week later.

Step 3Step 3

​Detailed Instructions Inside

​​BILINGUAL HOW-TO VIDEOS

​Visit HERKLINE USA on YouTube for step-by-step videos.

How to VideoHow to Video

SPL UNCLASSIFIED SECTION

Distributed by MarcasUSA, Inc.,

El Segundo, CA 90245 • HerklineUSA.com

Made in U.S.A

58-253-02v3.0

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

2 fl oz (59 mL)

​*Proper use of nit comb removes nits

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1988409Herklin 4 % / 0.33 % Medicated ShampooPSN1
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN1
1988409piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo [Herklin]SBD1
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD1
1988409Herklin (piperonyl butoxide 4 % / pyrethrins 0.33 % ) Medicated ShampooSY1
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75940-192-09Herklin Lice Treatment59 mL in 1 BOTTLESHAMPOO591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75940-192HERKLIN LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MARCASUSA LLC]1Current NDC, Legacy NDC, 1 package rows20180717_018e8b94-b52b-466c-8265-51fb68a67bcf.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
75940-19275940-192-09

Ingredients#

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

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

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
Herklin Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTMarcasUSA LLC018e8b94-b52b-466c-8265-51fb68a67bcf2018-07-16WarningsExact identifier
ndc (package): 75940-192-09
ndc (product): 75940-192
ndc11 (package): 75940019209
spl id: 3fbdf14a-eb00-4fd1-b00e-01f8354f04cb
spl set id: 018e8b94-b52b-466c-8265-51fb68a67bcf

Reported adverse events (FAERS/openFDA)#

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