Herklin®

Herklin®
SPL v1
SPL
SPL Set ID 908f9a80-d1cf-448e-8e35-e4dc856e0e99
Route
TOPICAL
Published
Effective Date 2017-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piperonyl Butoxide (40 mg) Pyrethrum Extract (0.033 mg)
Inactive Ingredients
Peg-25 Hydrogenated Castor Oil Polyquaternium-10 (125 Mpa.s At 2%) Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-10-29

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

treats head, pubic (crab), and body lice

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53413-1
  • Questions or comments call (515) 276-1586
  • see package insert for additional information
Section 55105-1
Active ingredients Purposes
Piperonyl butoxide 4% Lice treatment
Pyrethrum extract (equivalent to 0.33% pyrethrins) Lice treatment
Warnings

For external use only

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
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.

Other Information
  • do not freeze
  • store at controlled room temperature, 20 °C to 25 °C (68 °F to 77 °F)
Inactive Ingredients

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

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


Structured Label Content

Uses

treats head, pubic (crab), and body lice

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53413-1 (53413-1)
  • Questions or comments call (515) 276-1586
  • see package insert for additional information
Section 55105-1 (55105-1)
Active ingredients Purposes
Piperonyl butoxide 4% Lice treatment
Pyrethrum extract (equivalent to 0.33% pyrethrins) Lice treatment
Warnings

For external use only

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
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.

Other Information (Other information)
  • do not freeze
  • store at controlled room temperature, 20 °C to 25 °C (68 °F to 77 °F)
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (Stop use and ask a doctor if)
  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs
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.
Principal Display Panel 236 Ml Bottle Carton (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.


Advanced Ingredient Data


Raw Label Data

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