Lice MD

Manufacturer
RB Health (US) LLC
Effective date
2021-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:26:54

Label at a glance#

ProductLice MD Complete
Active ingredientPyrethrum Extract, Piperonyl Butoxide
Label structure14 sections

Indications and uses

treats head, pubic (crab), and body lice

Dosage and administration

Important: Read warnings before use. Read leaflet inside carton for complete directions 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 ...

Storage and handling

store at 20-25°C (68-77°F). Avoid excessive heat. keep carton for important product information see leaflet inside carton for additional information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LiceMD® Treatment Gel

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Piperonyl butoxide (4%)Lice treatment
Pyrethrum extract (equivalent to pyrethrins 0.33%)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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are 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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Important: Read warnings before use. Read leaflet inside carton for complete directions 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 this product thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck.
    • allow this product to remain on hair or other affected area for 10 minutes, but no longer
    • wash area thoroughly with warm water and soap or shampoo
    • for head lice, towel dry hair and comb out tangles
    Remove lice and their eggs (nits)
    • use a fine-tooth comb or the 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 with this product 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

  • store at 20-25°C (68-77°F). Avoid excessive heat.
  • keep carton for important product information
  • see leaflet inside carton for additional information

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, carboxymethylcellulose sodium, dimethicone, fragrance, hydroxyethylcellulose, methylchloroisothiazolinone, methylisothiazolinone, petroleum distillates, water

Questions?

OTC - QUESTIONS SECTION

1-866-252-5327. You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

LiceMD Shampoo (Non-medicated)

Important: Read leaflet inside carton for complete directions before use.

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for use after treatment with LiceMD® Treatment Gel
    • rinse hair with warm water and apply LiceMD Shampoo (Non-Medicated)
    • thoroughly massage shampoo into the scalp and work into a lather
    • be sure to shampoo behind ears and on back of neck too
    • rinse thoroughly with warm water
    • repeat if necessary to remove all traces of LiceMD® Treatment Gel
    • towel dry hair and comb out tangles with a wide-tooth comb
  • This shampoo does not kill lice or their eggs (nits). Use this shampoo only after using the LiceMD® Treatment Gel contained in this carton or another similar lice treatment product.

Ingredients

INACTIVE INGREDIENT SECTION

water, sodium laureth sulfate, sodium chloride, cocamidopropyl betaine, cocamide DEA, lauramide DEA, fragrance, diethanolamine, glycerin, polysorbate-20, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, propylene glycol, dimethicone

Questions?

OTC - QUESTIONS SECTION

1-866-252-5327
store at 20-25°C (68-77°F).

SPL UNCLASSIFIED SECTION

LiceMD Shampoo Made in Canada
Throw-away Gloves Made in China

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SATISFACTION GUARANTEED
100%
GUARANTEE

OR YOUR MONEY BACK**

LiceMD®

COMPLETE KIT

NDC 63824-916-00

LiceMD®

COMPLETE KIT

with LiceMD® Treatment Gel [Pyrethrum Extract
(Equivalent to 0.33% Pyrethrins) with Piperonyl Butoxide 4%] Lice Treatment

KILLS LICE &
ELIMINATES
100% of THEIR EGGS*

TREAT - kill lice

COMB - eliminate 100% lice eggs

WASH - clean hair

KIT CONTAINS:
1 Lice Killing Gel 4 FL OZ (118mL)
1 Comb
1 Shampoo (Non medicated) 4 FL OZ (118mL)
2 Pairs of gloves

* The LiceMD® comb eliminated 100% lice eggs in laboratory testing

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-916-002021-11-17C16284748780-19d75b9d0-2aca-f424-e053-dadaa90a57ceLice MD ® Complete Kit
63824-916-002020-01-31C16284748780-19d75b9d0-2aca-f424-e053-dadaa90a57ceLice MD ® Complete Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-916-00ML - Milliliter63824-9167a1dde5f-34cc-406f-b7c1-0b3904f9100a22015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Piperonyl ButoxideACTIVE INGREDIENTLWK91TU9AH2
Pyrethrum ExtractACTIVE INGREDIENTZUM06L90GV2
Piperonyl ButoxideACTIVE MOIETYLWK91TU9AH2
Pyrethrum ExtractACTIVE MOIETYZUM06L90GV2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171K2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS3112
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O2
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPN2
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-91663824-916-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 76 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM, SOLUBLE / BUCCAL47 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYRUP / ORAL26.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRALESIONAL15 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / BUCCAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE / ORAL160 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRA-ARTICULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, DELAYED RELEASE / ORAL4.2 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ENTERAL2920 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE, FOR SUSPENSION / ORAL15.63 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, EXTENDED RELEASE / ORAL933 mgExact identifier — unii candidate
44 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
44 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION/ DROPS / ORAL12.85 mg/2.5mlExact identifier — unii candidate
44 equally ranked IID candidates

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
20a7b015-696e-4062-953b-aa47b53b00667509990f-0bc8-44dc-9678-05b27f2c13682021-11-17WarningsExact identifier
spl id: 20a7b015-696e-4062-953b-aa47b53b0066
spl set id: 7509990f-0bc8-44dc-9678-05b27f2c1368

Reported adverse events (FAERS/openFDA)#

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