HERKLIN- piperonyl butoxide and pyrethrum extract shampoo

Herklin by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
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

• 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 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 °C to 25 °C (68 °F to 77 °F)

• 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

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

HERKLIN 
piperonyl butoxide and pyrethrum extract shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75940-171
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	0.033 mg  in 1 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: 75940-171-04	1 in 1 CARTON	10/29/2017
1		236 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	10/29/2017

Labeler - MarcusUSA (016139820)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co.Inc		005290028	MANUFACTURE(75940-171)