HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum 
Estrella Brands, 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 Kit

Drug Facts

Active ingredients

Piperonyl butoxide 4% 

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purposes

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

Treat

Remove lice and their eggs (nits)

children under 2 years: ask a doctor

Other information

Inactive ingredients

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

HERKLIN Lice Treatment Kit (72902-001-02)

Outer PackageInner Package

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72902-001
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72902-001-021 in 1 KIT04/01/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 59 mL
Part 1 of 1
HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum shampoo
Product Information
Item Code (Source)NDC:72902-000
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
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72902-000-021 in 1 CARTON
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G04/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G04/01/2019
Labeler - Estrella Brands, LLC (116929354)

Revised: 2/2019
Document Id: 82533bd1-50ef-5f84-e053-2a91aa0a23ee
Set id: 6a821b2e-f2b0-42bb-bfc8-4d320c36f6ab
Version: 4
Effective Time: 20190220
 
Estrella Brands, LLC