Label: DISCOUNT LICE TREATMENT- piperonyl butoxide, pyrethrum extract kit
- NDC Code(s): 53943-255-01
- Packager: Discount drug mart
- 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.
Updated May 14, 2019
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- Active ingredient
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
- Important: Read warnings before use
- Adults and children 2 years and over:
- 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
- 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
- Inactive ingredients
- Package Insert
- Principal Display Panel
INGREDIENTS AND APPEARANCE
DISCOUNT LICE TREATMENT
piperonyl butoxide, pyrethrum extract kit
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-255 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-255-01 1 in 1 CARTON; Type 0: Not a Combination Product 01/03/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 1 of 1 LICE KILLING
piperonyl butoxide, pyrethrum extract shampoo
Product Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE 40 mg in 1 mL PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT 3.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J) 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 1 118 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 02/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358 10/28/2010 Labeler - Discount drug mart (047741335) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(53943-255)