HERKLIN- piperonyl butoxide and pyrethrum extract shampoo 
MarcusUSA

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®

Drug Facts

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

Uses

treats head, pubic (crab), 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 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 in 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

Other information

  • Questions or comments call (515) 276-1586
  • see package insert for additional information

Inactive ingredients

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

Distributed by: MarcasUSA, LLC
El Segundo CA, 90245

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

8 fl oz (236 mL)

*Proper use of nit comb removes nits.

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton
HERKLIN 
piperonyl butoxide and pyrethrum extract shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-171
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 extract0.033 mg  in 1 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:75940-171-041 in 1 CARTON10/29/2017
1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358G10/29/2017
Labeler - MarcusUSA (016139820)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co.Inc005290028MANUFACTURE(75940-171)

Revised: 11/2017
Document Id: 6c7c7bed-7527-44ce-9616-f155db2e4753
Set id: 908f9a80-d1cf-448e-8e35-e4dc856e0e99
Version: 1
Effective Time: 20171107
 
MarcusUSA