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.

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Lice MD®
Complete Kit

LiceMD® Treatment Gel

Drug Facts

Active ingredients Purpose
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 Type HUMAN OTC DRUG Item Code (Source) NDC:63824-916
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-916-00 1 in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, DISPENSING 118 mL
Part 2 1 BOTTLE 118 mL
Part 1 of 2
LICEMD  TREATMENT
pyrethrum extract and piperonyl butoxide gel
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract 0.33 g  in 100 mL
Piperonyl Butoxide (UNII: LWK91TU9AH) (Piperonyl Butoxide - UNII:LWK91TU9AH) Piperonyl Butoxide 4 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
carboxymethylcellulose sodium (UNII: K679OBS311)  
dimethicone (UNII: 92RU3N3Y1O)  
methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
methylisothiazolinone (UNII: 229D0E1QFA)  
water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 118 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358G 11/01/2012
Part 2 of 2
LICEMD  (NON-MEDICATED)
shampoos (non-coloring) shampoo
Product Information
Route of Administration TOPICAL DEA Schedule     
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR water (UNII: 059QF0KO0R)  
INGR sodium laureth-3 sulfate (UNII: BPV390UAP0)  
INGR citric acid monohydrate (UNII: 2968PHW8QP)  
INGR cocamidopropyl betaine (UNII: 5OCF3O11KX)  
INGR sodium chloride (UNII: 451W47IQ8X)  
INGR PEG-150 pentaerythrityl tetrastearate (UNII: 8L4OOQ76AM)  
INGR PPG-2 hydroxyethyl cocamide (UNII: 34N07GUJ3X)  
INGR polysorbate 20 (UNII: 7T1F30V5YH)  
INGR edetate sodium (UNII: MP1J8420LU)  
INGR magnesium nitrate (UNII: 77CBG3UN78)  
INGR propylene glycol (UNII: 6DC9Q167V3)  
INGR sodium hydroxide (UNII: 55X04QC32I)  
INGR methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
INGR magnesium chloride (UNII: 02F3473H9O)  
INGR dimethicone (UNII: 92RU3N3Y1O)  
INGR methylisothiazolinone (UNII: 229D0E1QFA)  
INGR edetate trisodium (UNII: 420IP921MB)  
INGR sodium ferrocyanide (UNII: 5HT6X21AID)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 11/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358G 11/01/2012
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