HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum extract shampoo

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]

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.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

​​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, beginin 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 head.  Longer hair may take 1 to 2 hours.
• life 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 froom coming back.
• after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
• 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:​ aska doctor

​Other Information

• do not freeze
• store at controlled room temperature, 20 °C to 25 ° C (68 ºF to 77 ºF)
• Questions or comments call (844) 437-5546
• see package insert for additional information

Consumer Information

Kills Lice & Eliminates Nits in 3 simple steps

​​​STEP 1: APPLY  APLIQUE

Apply shampoo ​on dry hair​​ for 10 minutes.

​

STEP 2: REMOVE RETIRE

Remove lice and nits with comb provided.

​STEP 3: REPEAT REPITA

​Repeat treatment 1 week later.

​Detailed Instructions Inside

​​BILINGUAL HOW-TO VIDEOS

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum extract shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75940-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	4 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	0.33 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75940-192-09	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	07/16/2018

Labeler - MarcasUSA LLC (016139820)

Registrant - MarcasUSA LLC (016139820)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co.Inc		005290028	manufacture(75940-192)