LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo 
Weeks & Leo Co., Inc.

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 Killing shampoo

Active ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

treats head, pubic (crab), and body lice

Purpose

Lice treatment

Warnings

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

Important: Read warnings before use
Adults and children 2 years and over:

Inspect

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

Package Insert

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Principal Display Panel

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LICE KILLING SHAMPOO

For the treatment of Head Lice, Pubic (Crab) Lice and Body Lice

DIRECTIONS

Important: Read warnings before using this product. A second treatment must be done in 7-10 days to kill anu newly hatched lice eggs (nits)

Inspect

examine each household member with a magnifying glass in bright light for lice/eggs (nits)
look for tiny eggs (nits) near scalp, beginning at the back of neck and behind ears
examine small sections of hair
eggs (nits) stick to the hair
if either lice or eggs (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

To Remove Lice and Their Eggs (Nits)

use a special lice/nit or fine-toothed comb (included). Remove any remaining eggs (nits) by hand, using a throwaway glove
hair should remain slightly damp while removing eggs (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 the head. Longer hair may take 1 to 2 hours
lift a 1- to 2-inch wide strand of hair. Place comb firm, even motion away from scalp
pin back each strand of hair after combing
clean comb often. Wipe eggs (nits) away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back
after combing, thoroughly recheck for lice/eggs (nits). Repeat combing if necessary
check daily for any lice/eggs (nits) that you missed
a second treatment must be done within 7 to 10 days to kill any newly hatched lice/eggs (nits)
if infestation continues, see a doctor for other treatments

1. HEAD LICE

head lice lay small white eggs (nits) on the hair shaft close to the scalp
eggs (nits) are most easily found on the back of the neck or behind the ears
disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes
items that cannot be washed, dry cleaned or stored may be sprayed with a product designed for this purpose
soak all combs and brushes in hot water [above 54 C (130 F)] for at least 10 minutes
vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people

2. PUBIC (CRAB) LICE

pubic (crab) lice may be contracted by sexual contact
sexual partners should be treated simultaneously to avoid reinfestation
lice are very small and look like brown or grey dots on the skin
pubic (crab) lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface
pubic (crab) lice may be present on the short hairs of the groin, thighs, trunk, and underarms, -and occasionally on the beard, eyelids, and mustache
disinfect underwear by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes

3. BODY LICE

body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit areas
body lice feed on skin then return to clothing to lay their eggs (nits)
disinfect clothing by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 mintues
do not seal clothing in a plastic bag because eggs (nits) can remain dormant for up to 30 days

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LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-310
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
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
1NDC:11383-310-021 in 1 CARTON05/17/2021
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 finalpart358G05/17/2021
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(11383-310)

Revised: 6/2021
Document Id: c44689ae-2a05-5ef6-e053-2995a90a9532
Set id: c3647aca-7fb9-e2f4-e053-2995a90a7acb
Version: 2
Effective Time: 20210608
 
Weeks & Leo Co., Inc.