Herklin Lice Treatment

Herklin Lice Treatment
SPL v1
SPL
SPL Set ID 018e8b94-b52b-466c-8265-51fb68a67bcf
Route
TOPICAL
Published
Effective Date 2018-07-16
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
Peg-25 Hydrogenated Castor Oil Polyquaternium-10 (125 Mpa.s At 2%) Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-07-16

Description

Active Ingredients Piperonyl butoxide 4%.........................................................................Lice Treatment Pyrethrum extract (equivalent to 0.33 % pyrethrins.................................Lice Treatment

Purpose

Treatment head, pubic (crab), and body lice


Medication Information

Purpose

Treatment head, pubic (crab), and body lice

Description

Active Ingredients Piperonyl butoxide 4%.........................................................................Lice Treatment Pyrethrum extract (equivalent to 0.33 % pyrethrins.................................Lice Treatment

Section 42229-5

Distributed by MarcasUSA, Inc.,

El Segundo, CA 90245 • HerklineUSA.com

Made in U.S.A

58-253-02v3.0

Section 44425-7
  • 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
​uses

​Uses treats head lice, pubic (crab) lice, and body lice

Drug Facts

Active Ingredients

Piperonyl butoxide 4%.........................................................................Lice Treatment

Pyrethrum extract (equivalent to 0.33 % pyrethrins.................................Lice Treatment

​warnings

​ ​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

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.

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.
​inactive Ingredients

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

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.

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


Structured Label Content

Section 42229-5 (42229-5)

Distributed by MarcasUSA, Inc.,

El Segundo, CA 90245 • HerklineUSA.com

Made in U.S.A

58-253-02v3.0

Section 44425-7 (44425-7)
  • 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
Purpose

Treatment head, pubic (crab), and body lice

​uses (​Uses)

​Uses treats head lice, pubic (crab) lice, and body lice

Drug Facts

Active Ingredients

Piperonyl butoxide 4%.........................................................................Lice Treatment

Pyrethrum extract (equivalent to 0.33 % pyrethrins.................................Lice Treatment

​warnings (​Warnings)

​ ​directions (​ ​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

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.

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.
​inactive Ingredients (​Inactive Ingredients)

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

Stop Use and Ask Doctor If (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 (Keep out of reach of children)

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

Ask A Doctor Before Us If You Are (Ask a doctor before us if you are)
  • allergic to ragweed, May cause breathing difficulty or an asthmatic attack.
For External Use Only. Do Not Use (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.
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

2 fl oz (59 mL)

​*Proper use of nit comb removes nits


Advanced Ingredient Data


Raw Label Data

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