LICE MD COMPLETE- pyrethrum extract and piperonyl butoxide kit

Lice MD by

Drug Labeling and Warnings

Lice MD by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LiceMD® Treatment Gel

Drug Facts

ACTIVE INGREDIENT

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

• 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.

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

• 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).

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

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

INGREDIENTS AND APPEARANCE

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

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

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)