Active Ingredients And Purpose
Active ingredient
Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)
Purpose
Lice treatment
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
Key Label Information#
Uses
Uses
treats head, pubic (crab), and body lice
Warnings
Warnings
Directions And Dosage
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 Label Information
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
Principal Display Panel
Label Images#
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#
- Lice Killing
- Piperonyl butoxide, Pyrethrum extract
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11383-310 | 11383-310-02 |
Ingredients#
| 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 |
Complete SPL Sections#
Active ingredient
Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)
Uses
treats head, pubic (crab), and body lice
Purpose
Lice treatment
Warnings
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