FDA.reportPublic FDA data

Quality Choice Lice Treatment

Manufacturer
Chain Drug Marketing Association | Weeks & Leo Co., Inc.
Effective date
2023-12-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:03:46

Label at a glance#

ProductQuality 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

Consumer Information - Package Insert

SPL PATIENT PACKAGE INSERT SECTION

Principal Display PanelPrincipal Display Panel

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice

The all in one lice solution for your family

Compare to the Active Ingredients in RID® Shampoo†

with maximum strength Shampoo

1 treat shampoo

2 remove comb/gel

3 control spray

Instrucciones en español incluidas

Principal Display PanelPrincipal Display Panel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-525-012025-01-30C16284748780-12cef2736-80a2-d83d-e063-dadaa90ab31fQuality Choice Lice treatment Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-525-01Quality Choice Lice Treatment1 in 1 CARTONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-525QUALITY CHOICE LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) KIT [CHAIN DRUG MARKETING ASSOCIATION]8Legacy NDC, 1 package rows20231210_89018c4a-69f3-64ff-e053-2a95a90a238a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-525-01EA - Each63868-5259b98fc55-a1ba-4688-938b-bf32fa39685b12022-12-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-52563868-525-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c1ad894-fb84-90bb-e063-6394a90a932a89018c4a-69f3-64ff-e053-2a95a90a238a2023-12-09WarningsExact identifier
spl id: 0c1ad894-fb84-90bb-e063-6394a90a932a
spl set id: 89018c4a-69f3-64ff-e053-2a95a90a238a

Reported adverse events (FAERS/openFDA)#

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