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leader lice solution by Cardinal Health

Dosage form: kit
Ingredients: PIPERONYL BUTOXIDE 4mL in 100mL, PYRETHRUM EXTRACT 0.33mL in 100mL;
Labeler: Cardinal Health
NDC Code: 37205-519

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.

Cardinal Health Lice Solution Kit Drug Facts

Active ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

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 into 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

Shake well before using

  • Important: Read warnings 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 thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.
  • allow product to remain for 10 minutes, but no longer
  • use warm water to form a lather, shampoo, then thoroughly rinse
  • for head lice, towel dry hair and comb out tangles

Remove lice and their eggs (nits)

  • use a fine-tooth or 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 the 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 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)
  • keep carton for important product information
  • see package insert for additional information

Inactive ingredients

benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, water, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to RID® Lice Killing Shampoo active ingredients

Lice Solution Kit

1-2-3 Lice Control System

Instrucciones En Español Incluidas

Step 1 Lice Killing Shampoo

Works fast to kill lice and eggs

Helps children return to school nit free

Step 2 Egg & Nit Combing Gel

Use after lice killing treatment to help prevent reinfestation

Makes egg & nit removal faster & easier

Step 3 Home Lice Control Spray

For bedding and furniture

Kills lice and their eggs on mattresses, furniture, car interiors and other non-washable items

Keep Out of Reach of Children

Caution

See Back and Side Panel for Additional Information

# Nit Comb Included

Lice Solution Kit Carton

LEADER LICE SOLUTION 
piperonyl butoxide, pyrethrum extract kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-519
Packaging
#Item CodePackage Description
1NDC:37205-519-031 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 57 g
Part 1 of 2
LEADER LICE KILLING  MAXIMUM STRENGTH
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (PIPERONAL) PIPERONYL BUTOXIDE4 mL  in 100 mL
PYRETHRUM EXTRACT (PYRETHRUM EXTRACT) PYRETHRUM EXTRACT0.33 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
WATER 
XANTHAN GUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G
Part 2 of 2
EGG AND NIT 
combing aid gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCOLIC ACID 
POTASSIUM HYDROXIDE 
Packaging
#Item CodePackage Description
157 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G10/18/2007
Labeler - Cardinal Health (097537435)

Revised: 05/2009
 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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