FDA.reportPublic FDA data

Best Choice Lice Treatment

Manufacturer
Associated Wholesale Grocers, Inc. | Weeks & Leo Co., Inc.
Effective date
2023-12-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:05:29

Label at a glance#

ProductBest Choice Lice Treatment
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure9 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 Treat app...

Storage and handling

do not freeze store at controlled room temperature 20°-25°C (68°-77°F) see package insert for additional information

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

INDICATIONS & USAGE SECTION

treats head, pubic (crab), and body lice

Purpose

OTC - PURPOSE SECTION

Lice treatment

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 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 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

Other information

STORAGE AND HANDLING SECTION

  • do not freeze
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • 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

Principal Display PanelPrincipal Display Panel

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice

Complete Lice Treatment Kit

THE ALL IN ONE SOLUTION FOR YOUR FAMILY

Compare to the Active Ingredients in RID® Shampoo†

MAXIMUM STRENGTH

3-Step Lice Solution Kit

1 TREAT SHAMPOO

2 REMOVE COMB/GEL

3 CONTROL SPRAY

CAUTION: KEEP OUT OF REACH OF CHILDREN

Instrucciones en español incluidas

SHAMPOO 4 FL OZ (118 mL)

COMBING SPRAY 2 FL OZ (59mL)

LICE SPRAY NET WT 5 OZ (142g)

1 NIT REMOVAL COMB

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN6
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD6
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-522-01Best Choice Lice Treatment1 in 1 CARTONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-522BEST CHOICE LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) KIT [ASSOCIATED WHOLESALE GROCERS, INC.]6Current NDC, Legacy NDC, 1 package rows20231223_89019cc4-9ff4-3fd5-e053-2a95a90a3125.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63941-52263941-522-01
63941-253

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3INGR
AMODIMETHICONE (800 CST)363Z2T48P7INGR
POLYSORBATE 207T1F30V5YHINGR
CETRIMONIUM CHLORIDEUC9PE95IBPINGR
TRIDECETH-12YFY3KG5Y7OINGR
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WINGR
GLYCERINPDC6A3C0OXINGR
PANTHENOLWV9CM0O67ZINGR
PHENOXYETHANOLHIE492ZZ3TINGR
WATER059QF0KO0RINGR
POLYQUATERNIUM-10 (400 MPA.S AT 2%)HB1401PQFSIACT
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PEG-25 HYDROGENATED CASTOR OIL0ZNO9PJJ9JIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTAssociated Wholesale Grocers, Inc.89019cc4-9ff4-3fd5-e053-2a95a90a31252023-12-09WarningsExact identifier
ndc (package): 63941-522-01
ndc (product): 63941-522
ndc11 (package): 63941052201
spl id: 0c181dc9-a05b-7b4f-e063-6294a90a5eee
spl set id: 89019cc4-9ff4-3fd5-e053-2a95a90a3125
Best Choice Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTValu Merchandisers, CO.488061ad-1a5f-57d3-e054-00144ff88e882017-02-14WarningsExact identifier
ndc (product): 63941-253

Reported adverse events (FAERS/openFDA)#

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