Your browser does not support JavaScript! LICEMD TREATMENT (PYRETHRUM EXTRACT AND PIPERONYL BUTOXIDE) GEL [RECKITT BENCKISER LLC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

LICEMD TREATMENT (pyrethrum extract and piperonyl butoxide) gel
[Reckitt Benckiser LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

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

Uses

treats head, pubic (crab), and body lice

Warnings

For external use only

Do not use

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

When using this product

  • 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

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

Keep out of reach of children.

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

Directions

  • 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

  • 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

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

Questions?

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

LiceMD® Comb

Directions

For Head Lice

Please read the leaflet for complete directions before use.

Use AFTER LiceMD treatment gel and shampooing steps.

  • comb out the dead lice, eggs, and nits with the enclosed LiceMD comb. Please read the entire leaflet for complete directions. This step is very important.
  • start at the top of the head, comb one section at a time and it is important to get the teeth of the comb very close to the scalp. Combing can take over an hour.
  • if hair dries before combing, dampen slightly with warm water
  • soak all combs, bobby pins, and hair clips in hot water [above 54°C (130°F)] after combing
  • check daily for any lice/nits that you have missed

Throw-Away Gloves

  • 100% nitrile
  • powder-free
  • latex-free
  • non-sterile
  • single-use

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

LiceMD®
TREATMENT GEL

SATISFACTION GUARANTEED
100% GUARANTEE
OR YOUR MONEY BACK**

NDC 63824-908-00

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

CONTAINS:

1 Lice Killing Gel 4 FL OZ (118mL)
1 Comb
2 Pairs of
  Throw-Away
  Gloves

*The LiceMD Comb
  eliminated 100%
  lice eggs in
  laboratory testing

Principal Display Panel - 118 mL Bottle Carton
LICEMD   TREATMENT
pyrethrum extract and piperonyl butoxide gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-900
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrethrum Extract (Pyrethrum Extract) Pyrethrum Extract0.33 g  in 100 mL
Piperonyl Butoxide (Piperonyl Butoxide) Piperonyl Butoxide4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
butylated hydroxytoluene 
carboxymethylcellulose sodium 
dimethicone 
methylchloroisothiazolinone 
methylisothiazolinone 
water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-900-641 in 1 CARTON
1118 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358G11/01/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 1/2013
 
Reckitt Benckiser LLC

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services