FDA.reportPublic FDA data

Mata Piojos Lice

Manufacturer
Grandall Distributing Company Inc | WEEKS & LEO CO,INC.
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:07:00

Label at a glance#

ProductMata Piojos Lice
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure8 sections

Indications and uses

treat head, pubic (crab), and body lice

Dosage and administration

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 ap...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

OTC - PURPOSE SECTION

Lice treatment

Uses

INDICATIONS & USAGE SECTION

treat head, pubic (crab), and body lice

Warnings

WARNINGS SECTION

For external use only

Do not use 

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • allergic to regweed. May cause breathing difficulty or an asthmatic attack.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 nick.
  • 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 cut 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).
  • hari 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

SPL UNCLASSIFIED SECTION

  • do not freeze
  • store at controlled room temperature, 20°C to 25°C (68° F to 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 INGREDIENT SECTION

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

Package Insert

SPL PATIENT PACKAGE INSERT SECTION

InsertInsert

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48201-36748201-367-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-25 HYDROGENATED CASTOR OIL0ZNO9PJJ9JIACT
WATER059QF0KO0RIACT
PIPERONYL BUTOXIDELWK91TU9AHACTIB
PYRETHRUM EXTRACTZUM06L90GVACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0fa519d3-bf89-a18b-e063-6294a90ab07bf7fd83b8-4e8d-480d-af08-5f8784ae6d102024-01-23WarningsExact identifier
spl set id: f7fd83b8-4e8d-480d-af08-5f8784ae6d10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.