FDA Label for Herklin Lice Treatment

View Indications, Usage & Precautions

Herklin Lice Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Marcasusa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


​​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 °F to 77 °F)
  • 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.


Other



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


* Please review the disclaimer below.