Mata Piojos Lice

Manufacturer
GRANDALL DISTRIBUTING, LLC
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:40:56

Label at a glance#

ProductMata Piojos Lice
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure7 sections

Indications and uses

treats 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. Trea...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

OTC - PURPOSE SECTION

Lice treatment

Uses

INDICATIONS & USAGE SECTION

treats 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 ragweed. 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 into 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 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 nitsif hair dries during combing, dampen slightly with waterfor head lice, part hair into sections. Do one section at a time starting on top of the 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Mata Piojos_Lice Shampoo_2oz01b LBL_Mata Piojos_Lice Shampoo_2oz

01b UC_Mata Piojos_Lice Shampoo_8oz01b UC_Mata Piojos_Lice Shampoo_8oz

01b Insert_Mata Piojos_Lice Shampoo01b Insert_Mata Piojos_Lice Shampoo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN8
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD8
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128026801b UC_Mata Piojos_Lice Shampoo_8oz.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-006-08Mata Piojos Lice237 mL in 1 BOTTLESHAMPOO2378
48201-006-08Mata Piojos Lice1 in 1 CARTONSHAMPOO18
48201-006-59Mata Piojos Lice59 mL in 1 BOTTLESHAMPOO598
48201-006-59Mata Piojos Lice1 in 1 CARTONSHAMPOO18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PIPERONYL BUTOXIDEACTIVE INGREDIENTLWK91TU9AH1
PYRETHRUM EXTRACTACTIVE INGREDIENTZUM06L90GV1
PIPERONYL BUTOXIDEACTIVE MOIETYLWK91TU9AH1
PYRETHRUM EXTRACTACTIVE MOIETYZUM06L90GV1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48201-00648201-006-59, 48201-006-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PIPERONYL BUTOXIDELWK91TU9AHACTIB
PYRETHRUM EXTRACTZUM06L90GVACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-01-23full-release2026-06-01 00:07:44

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
Mata Piojos LicePIPERONYL BUTOXIDE, PYRETHRUM EXTRACTGRANDALL DISTRIBUTING, LLC1de4e361-4e7b-4f7e-b6c8-30fa21e75bea2025-10-27WarningsExact identifier
ndc (package): 48201-006-08
ndc (package): 48201-006-59
ndc (product): 48201-006
ndc11 (package): 48201000659
ndc11 (package): 48201000608
spl id: 422ba85b-f780-39da-e063-6294a90a6976
spl set id: 1de4e361-4e7b-4f7e-b6c8-30fa21e75bea

Reported adverse events (FAERS/openFDA)#

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