HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum extract 
MARCASUSA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Herklin Lice Treatment & Prevention Kit

Active ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

treats head, pubic (crab), and body lice

Purpose

Lice treatment

Warnings

For external use only

Do not use

  • 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

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

When using this product

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

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

Inspect

Treat

Remove lice and their eggs (nits)

Other information

Inactive ingredients

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

Package Insert

Consumer Information - Package Insert

English Insert

nsert 1 .jpg

Spanish insert

Insert 2 .jpg

Principal Display Panel

Herklin

LICE TREATMENT 7 PREVENTION KIT

With Natural Head Lice Repellent to help prevent Lice reinfestation after shamporr treatment

con repelente de piojos natural para ayudar prevenir la reinfestacion de piojos despues del tratmiento con shampoo

Plus NATURAL HEAD LICE REPLEELLENT TO PREVENT REINFESTATION

Kills Lice & Eliminates Nits*

Mata Los piojos y elimina las liendres

ONLY 3 STEPS/ SOLO 3 PASOS

1 Eliminate 2 Remove 3 Control

Effective & Safe for ages 2+

CAUTION: KEEP OUT OF REACH OF CHILDREN

Instrucciones en español incluidas

SHAMPOO 8 FL OZ

Natural lice repellent spray

1 NIT REMOVAL COMB

herklin kit .jpg

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum extract kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-182
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75940-182-081 in 1 CARTON; Type 0: Not a Combination Product01/03/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE 118 mL
Part 1 of 1
LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE40 mg  in 1 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT3.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
Product Characteristics
Coloryellow (cloudy to transparent, cream to straw) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G02/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35810/28/2010
Labeler - MARCASUSA LLC (016139820)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(75940-182)

Revised: 4/2019
Document Id: 87ae4f4f-3e10-0495-e053-2a95a90a63d2
Set id: 87ae6697-7b8d-7ee7-e053-2a95a90a487c
Version: 6
Effective Time: 20190429
 
MARCASUSA LLC