Herklin Shampoo
FDA Label NDC 75940-171

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marcususa for the product Herklin (NDC 75940-171). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, ask a doctor before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by: MarcasUSA, LLC
El Segundo CA, 90245

Otc - Purpose

Active ingredientsPurposes
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

Otc - 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.

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)

Otc - Questions

  • 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

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.

Principal Display Panel (236 mL Bottle Carton)

Principal Display Panel (236 mL Bottle Carton)

* Please review the disclaimer below.