LICE MD COMPLETE- pyrethrum extract and piperonyl butoxide   
Reckitt Benckiser LLC

Disclaimer: 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.

----------

Lice MD®
Complete Kit

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

Other 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

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
Document Id: a2e9a7d2-9785-4145-9a3b-50ef08295afc
Set id: 7509990f-0bc8-44dc-9678-05b27f2c1368
Version: 2
Effective Time: 20130912
 
Reckitt Benckiser LLC