Your browser does not support JavaScript! LICE MD COMPLETE (PYRETHRUM EXTRACT AND PIPERONYL BUTOXIDE) KIT [RECKITT BENCKISER LLC]
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LICE MD COMPLETE (pyrethrum extract and piperonyl butoxide) kit
[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

LiceMD® Treatment Gel

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 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

  • 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

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?

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

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

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

PRINCIPAL DISPLAY PANEL - Kit Carton

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
LICE MD  COMPLETE
pyrethrum extract and piperonyl butoxide kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-916
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-916-001 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, DISPENSING 118 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
LICEMD  TREATMENT
pyrethrum extract and piperonyl butoxide gel
Product Information
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
1118 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G11/01/2012
Part 2 of 2
LICEMD  (NON-MEDICATED)
shampoos (non-coloring) shampoo
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRwater 
INGRsodium laureth-3 sulfate 
INGRcitric acid monohydrate 
INGRcocamidopropyl betaine 
INGRsodium chloride 
INGRPEG-150 pentaerythrityl tetrastearate 
INGRPPG-2 hydroxyethyl cocamide 
INGRpolysorbate 20 
INGRedetate sodium 
INGRmagnesium nitrate 
INGRpropylene glycol 
INGRsodium hydroxide 
INGRmethylchloroisothiazolinone 
INGRmagnesium chloride 
INGRdimethicone 
INGRmethylisothiazolinone 
INGRedetate trisodium 
INGRsodium ferrocyanide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G11/01/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 9/2013
 
Reckitt Benckiser LLC

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