HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum extract shampoo 
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

Drug Facts

Active Ingredients

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

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

​Inactive Ingredients

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

Purpose

Treatment head, pubic (crab), and body lice

​Uses

​Uses treats head lice, pubic (crab) lice, and body lice

​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 us 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 in eyes, flush with water right away
  • scalp itching or redness may occur.

Stop use and ask doctor if

  • breathing difficulty occurs
  • eye irrirtation 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

​Treat

​Remove lice and their eggs (nits)

​Other Information

Consumer Information

Kills Lice & Eliminates Nits in 3 simple steps

​STEP 1: APPLY • APLIQUE

Apply shampoo ​on dry hair​ for 10 minutes.

Step 1

STEP 2: REMOVE • RETIRE

Remove lice and nits with comb provided.

Step 2

​STEP 3: REPEAT • REPITA

​Repeat treatment 1 week later.

Step 3

​Detailed Instructions Inside

​BILINGUAL HOW-TO VIDEOS

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

How to Video

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

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

Carton

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75940-192-0959 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G07/16/2018
Labeler - MarcasUSA LLC (016139820)
Registrant - MarcasUSA LLC (016139820)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co.Inc005290028manufacture(75940-192)

Revised: 7/2018
Document Id: 3fbdf14a-eb00-4fd1-b00e-01f8354f04cb
Set id: 018e8b94-b52b-466c-8265-51fb68a67bcf
Version: 1
Effective Time: 20180716
 
MarcasUSA LLC