Indications and uses
treats head, pubic (crab), and body lice
Lice Killing
- Manufacturer
- Weeks & Leo Co., Inc.
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:33
Label at a glance#
ProductLice Killing
Active ingredientPIPERONYL BUTOXIDE, PYRETHRUM EXTRACT
Label structure9 sections
Dosage and administration
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 app...
Storage and handling
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Piperonyl butoxide 4%
Pyrethrum extract (equivalent to 0.33% pyrethrins)
Uses
treats head, pubic (crab), and body lice
Purpose
Lice treatment
Warnings
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
SPL PATIENT PACKAGE INSERT SECTION
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11383-310-02 | Lice Killing | 59 mL in 1 BOTTLE | SHAMPOO | 59 | 3 | |
| 11383-310-02 | Lice Killing | 1 in 1 CARTON | SHAMPOO | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Lice Killing
- Piperonyl butoxide, Pyrethrum extract
- PIPERONYL BUTOXIDE
- PYRETHRUM EXTRACT
- POLYQUATERNIUM-10 (400 MPA.S AT 2%)
- AMMONIUM LAURETH-2 SULFATE
- ALCOHOL
- WATER
- PEG-25 HYDROGENATED CASTOR OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11383-310 | 11383-310-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PIPERONYL BUTOXIDE | LWK91TU9AH | ACTIB |
| PYRETHRUM EXTRACT | ZUM06L90GV | ACTIB |
| POLYQUATERNIUM-10 (400 MPA.S AT 2%) | HB1401PQFS | IACT |
| AMMONIUM LAURETH-2 SULFATE | 698O4Z48G6 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| PEG-25 HYDROGENATED CASTOR OIL | 0ZNO9PJJ9J | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lice Killing | PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT | Weeks & Leo Co., Inc. | c3647aca-7fb9-e2f4-e053-2995a90a7acb | 2024-12-13 | Warnings | 11383-310-02 11383-310 11383031002 2930e5c6-665b-eac1-e063-6294a90ae5d8 c3647aca-7fb9-e2f4-e053-2995a90a7acb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.