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NDC 70000-0353-01 Leader Lice Killing 4; .33 g/100mL; g/100mL Details

Leader Lice Killing 4; .33 g/100mL; g/100mL

Leader Lice Killing is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT.

MedlinePlus Drug Summary

Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.

Related Packages: 70000-0353-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pyrethrin and Piperonyl Butoxide Topical

Product Information

NDC	70000-0353
Product ID	70000-0353_82d1a6e4-3727-fb07-e053-2a91aa0a82d4
Associated GPIs	90909902104540
GCN Sequence Number	044462
GCN Sequence Number Description	piperonyl butoxide/pyrethrins SHAMPOO 4%-0.33% TOPICAL
HIC3	Q5R
HIC3 Description	TOPICAL ANTIPARASITICS
GCN	91071
HICL Sequence Number	004168
HICL Sequence Number Description	PIPERONYL BUTOXIDE/PYRETHRINS
Brand/Generic	Generic
Proprietary Name	Leader Lice Killing
Proprietary Name Suffix	n/a
Non-Proprietary Name	Piperonyl butoxide, Pyrethrum extract
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	4; .33
Active Ingredient Units	g/100mL; g/100mL
Substance Name	PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358G
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70000-0353-01 (70000035301)

Pricing Information	N/A
NDC Package Code	70000-0353-1
Billing NDC	70000035301
Package	1 BOTTLE in 1 CARTON (70000-0353-1) / 118 mL in 1 BOTTLE
Marketing Start Date	2019-02-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 82d1c92b-33f1-d39c-e053-2a91aa0ad846 Details

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 MAXIMUM 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:70000-0353
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0353-1	1 in 1 CARTON	02/21/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Cardinal Health (097537435)

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

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo Co., Inc.		005290028	manufacture(70000-0353)

Revised: 2/2019

Document Id: 82d1a6e4-3727-fb07-e053-2a91aa0a82d4

Set id: 82d1c92b-33f1-d39c-e053-2a91aa0ad846

Version: 5

Effective Time: 20190226