Herklin Lice Killing Shampoo

Herklin Lice Killing Shampoo
SPL v3
SPL
SPL Set ID c3647aca-7fb9-e2f4-e053-2995a90a7acb
Route
TOPICAL
Published
Effective Date 2024-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piperonyl Butoxide (4 g) Pyrethrum Extract (0.33 g)
Inactive Ingredients
Polyquaternium-10 (400 Mpa.s At 2%) Ammonium Laureth-2 Sulfate Alcohol Water Peg-25 Hydrogenated Castor Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-17

Description

Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice treatment


Medication Information

Purpose

Lice treatment

Description

Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

treats head, pubic (crab), and body lice

Section 42230-3

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

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.
Active Ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Other Information
  • do not freeze
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • to report serious side effects due to the use of this product 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

Principal Display Panel

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

Ask A Doctor Before Use If You Are
  • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

Structured Label Content

Uses

treats head, pubic (crab), and body lice

Section 42230-3 (42230-3)

Purpose

Lice treatment

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

Do Not Use (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.
Active Ingredient (Active ingredient)

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Other Information (Other information)
  • do not freeze
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • to report serious side effects due to the use of this product call 515-276-1586
  • see package insert for additional information
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

When Using This Product (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 (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 (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)
  • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

Advanced Ingredient Data


Raw Label Data

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