Label: LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo
- NDC Code(s): 68016-253-04
- Packager: PHARMACY VALUE ALLIANCE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 11, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Uses
- Purpose
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Warnings
For external use only
Do not use
near eyes
inside nose, mouth, or vaginaon 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 awayscalp itching or redness may occur
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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 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)
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
- Inactive ingredients
- Package Insert
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
LICE KILLING
piperonyl butoxide, pyrethrum extract shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-253 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 PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J) ALCOHOL (UNII: 3K9958V90M) AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6) POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) WATER (UNII: 059QF0KO0R) 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:68016-253-04 1 in 1 CARTON 10/12/2020 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 10/12/2020 Labeler - PHARMACY VALUE ALLIANCE LLC (101668460) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(68016-253)
