LICEMD TREATMENT- pyrethrum extract and piperonyl butoxide gel

LiceMD by

Drug Labeling and Warnings

LiceMD 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

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.

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LICEMD   TREATMENT
pyrethrum extract and piperonyl butoxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-900
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	NDC: 63824-900-64	1 in 1 CARTON
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

Labeler - Reckitt Benckiser LLC (094405024)