LEADER LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

treats head, pubic (crab), and body lice

Purpose

Lice treatment

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

• 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

• do not freeze
• store at controlled room temperature 20°-25°C (68°-77°F)
• to report serious side effects due to the use of this product call 515-276-1586
• see package insert for additional information

Inactive ingredients

ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

Package Insert

Principal Display Panel

LEADER MAAXIMUM LICE KILLING SHAMPOO

A Liquid Pediculicide For Human Use

Compare to RID® LICE KILLING SHAMPOO

4 fl oz (118ml)

INGREDIENTS AND APPEARANCE

LEADER LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	4 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	0.33 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)

Product Characteristics
Color	yellow (cloudy to transparent, cream to straw)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-253-04	1 in 1 CARTON	02/21/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	02/21/2019

Labeler - Cardinal Health (097537435)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(63517-253)