LEADER LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo
Leader Lice Killing by
Drug Labeling and Warnings
Leader Lice Killing by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active Ingredient
- Purposes
- Uses
-
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 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 -
Directions
Important: Read warnings before use
Adults and children 2 years and overInspect
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 productTreat
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 tanglesRemove lice and their eggs (nits)
se 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
- Inactive Ingredients
- Questions or comments?
-
Additional Information
Hair Length - Recommended Application for 1 Adult/Child
Short (ear length or shorter) Day 1: 1-2 oz; Day 7-10: 1-2oz; Total : 2-4oz
Medium (shoulder length) Day1: 2-3oz; Day 7-10: 2-3oz; Total: 4-6oz
Long (past shoulder length) Day 1: 3-4oz; Day 7-10: 3-4oz; Total: 6-8oz
Important: keep this outer carton for future reference
-
Package Insert
Consumer Information
LICE KILLING SHAMPOO
For the treatment of Head Lice, Pubic (Crab) Lice and Body Lice
DIRECTIONS
Important: Read warnings before using this product. A second treatment must be done in 7-10 days to kill anu newly hatched lice eggs (nits)
Inspect
examine each household member with a magnifying glass in bright light for lice/eggs (nits)
look for tiny eggs (nits) near scalp, beginning at the back of neck and behind ears
examine small sections of hair
eggs (nits) stick to the hair
if either lice or eggs (nits) are found, treat with this productTreat
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 tanglesTo Remove Lice and Their Eggs (Nits)
use a special lice/nit or fine-toothed comb (included). Remove any remaining eggs (nits) by hand, using a throwaway glove
hair should remain slightly damp while removing eggs (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 firm, even motion away from scalp
pin back each strand of hair after combing
clean comb often. Wipe eggs (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/eggs (nits). Repeat combing if necessary
check daily for any lice/eggs (nits) that you missed
a second treatment must be done within 7 to 10 days to kill any newly hatched lice/eggs (nits)
if infestation continues, see a doctor for other treatments1. HEAD LICE
head lice lay small white eggs (nits) on the hair shaft close to the scalp
eggs (nits) are most easily found on the back of the neck or behind the ears
disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes
items that cannot be washed, dry cleaned or stored may be sprayed with a product designed for this purpose
soak all combs and brushes in hot water [above 54 C (130 F)] for at least 10 minutes
vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people2. PUBIC (CRAB) LICE
pubic (crab) lice may be contracted by sexual contact
sexual partners should be treated simultaneously to avoid reinfestation
lice are very small and look like brown or grey dots on the skin
pubic (crab) lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface
pubic (crab) lice may be present on the short hairs of the groin, thighs, trunk, and underarms, -and occasionally on the beard, eyelids, and mustache
disinfect underwear by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes3. BODY LICE
body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit areas
body lice feed on skin then return to clothing to lay their eggs (nits)
disinfect clothing by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 mintues
do not seal clothing in a plastic bag because eggs (nits) can remain dormant for up to 30 daysSave this insert for future reference
SHAKE WELL BEFORE USING
-
PRINCIPAL DISPLAY PANEL
LEADER
Lice Killing Shampoo
Lice Treament Shampoo for Human Use
For the Treatment of Head Lice, Crab Lice and Body Lice
Compare to RID Lice Killing Shampoo active ingredients
100% Money Back Guarantee
4 fl oz (118 mL)
One Nit Removal Comb Included
NDC: 70000-0633-1
-
INGREDIENTS AND APPEARANCE
LEADER LICE KILLING
piperonyl butoxide, pyrethrum extract shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 70000-0633 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 ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J) AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70000-0633-1 1 in 1 CARTON 06/21/2023 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 Drug M031 06/21/2023 Labeler - LEADER/ Cardinal Health 110, Inc. (063997360) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(70000-0633)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.