HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum extract kit

Herklin Lice Treatment by

Drug Labeling and Warnings

Herklin Lice Treatment by is a Otc medication manufactured, distributed, or labeled by MARCASUSA LLC, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inspect

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

Remove lice and their eggs (nits)

• use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
• hair should remain slightly damp while removing 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 as close to scalp as possible and comb with a firm, even motion away from scalp.
• pin back each strand of hair after combing
• clean comb often. Wipe 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/nits. Repeat combing if necessary.
• check daily for any lice/nits that you missed
• a second treatment must be done in 7 to 10 days to kill any newly hatched lice
• if infestation continues, see a doctor for other treatments
• Children under 2 years: ask a doctor

Other information

• do not freeze
• store at controlled room temperature 20°-25°C (68°-77°F)
• see package insert for additional 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

Spanish insert

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

INGREDIENTS AND APPEARANCE

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum extract kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75940-182

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75940-182-08	1 in 1 CARTON; Type 0: Not a Combination Product	01/03/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE	118 mL

Part 1 of 1

LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	40 mg  in 1 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	3.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (cloudy to transparent, cream to straw)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	02/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358	10/28/2010

Labeler - MARCASUSA LLC (016139820)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(75940-182)